Re: Stryker Cited by U.S. FDA for Faulty Hip Parts

[Guest guest]

All I can say is thank god I researched, and didn't accept the plan

of one of the OS's I saw, who wanted to put in a Trident ceramic

THR. Feeling pretty happy with my Resurfaced hip.

Kellen in NM

>

>

> " U.S. regulators have warned medical device maker Stryker Corp about

> manufacturing problems linked to some malfunctioning hip implant

parts.

>

> At times, the malfunctions were serious enough to require additional

> surgery to fix the problems.

>

> A copy of a warning letter sent to Stryker was posted on the U.S.

Food

> and Drug Administration Web site on Tuesday. It said infractions at

> the company's Mahwah, New Jersey, plant included failure to fix

> quality problems, including those related to its Trident

> hip-replacement systems. The 11-page letter was dated Nov. 28. "

>

> Check story in the boston globe

>

> http://tinyurl.com/2ah4nr

>

> Aussie Margaret

>

[Guest guest]

STRYKER'S CERAMIC HIP TRIDENT RECEIVED WARNING FROM FDA

The second biggest manufacturer of artificial hip joints, Stryker,

got a warning from the USA agency for the defective quality of total

hip devices produced by the Company.

In the letter that was published on Agency's Webbsite January 17,

the Agency points specifically to the defects of the Company's

ceramic cup component TridentTM. (Click here for picture of the

Trident cup. It is the upper picture)

There were ongoing complaints that this cup is difficult to assemble

and to anchor stably in the patient's skeleton since 2005. Moreover,

the patients complained about noises from these cups, the noises

that sometimes heralded looming failures. The Agency states that

Stryker Company " had failed to correct the identified faults " .

Several letters were namely sent by the Agency during 2007 urging

the Company to correct the manufacturing faults that led to the

reported failures of the Trident component.

Interesting reading that evokes some questions:

First, the letter contains no data about the number / percentages of

the Trident cup failures. How big is the problem really?

Second, the timing of the Warning letter. It was sent on Nov 28,

2007, yet it was published on Agency's Webbside almost two months

later (January 17). Why this delay?

Third, the Warning Letter speaks about the failure of the Trident

ceramic cup leading to new operation (revision). How much was

published about it in the scientific journals?

Practically nothing. The Trident cup is a complicated construction,

consisting of three layers (See Ceramic Total hips). It was

introduced as " The right implant for the right performance " .

Surgeons working for Stryker published a report in 2005 about the

Trident component. Six USA surgeons followed 316 patients who were

operated on with the Trident cup. Three to five years after surgery

these surgeons noted that in these patients the ceramic in-liners

remained intact during this period. The surgeons concluded " Encasing

the alumina ceramic insert in a titanium sleeve seems to have

resolved the issue of insert chipping on impaction and supports the

continued use of Trident bearings in relatively young patients " .

In March 2007 independent British surgeons published a report that

came to completely different conclusion. They found that it is

difficult to place properly this Trident cup. (Click here for a

report about this article). The British surgeons suspected that the

difficulty to place the Trident cup properly is caused by the

fact " that the Trident shell deforms upon implantation, thereby

preventing complete seating of the liner " . And they conclude " We

have identified a potential problem with the Trident ace-tabular

shell when used in combination with its metal-backed ceramic liner " .

The FDA letter, however, offers another more probable explanation

of " this potential problem. The " adulterated methods used for

manufacturing of Trident cup " are producing components with wrong

dimensions, incompatible with each other. It is then impossible to

assemble properly the Trident's three cups together. Because these

cups are recommended for use in young patients so that these Trident

cup are supposed to stay in place several years, this is a serious

fault.

Information for you: It is always difficult to explain why the

doctors working for the manufacturing company find better results

for the products already on market than independent surgeons. The

suspicion that company's surgeons are forbidden to publish bad

results, often presented in lay press, is not much probable. If the

product is already on the market, the bad characteristics of the

product cannot be kept secret.

In my opinion Stryker Company should finance the American surgeons

(doctors D' and colleagues) who authored the 2005 article to

do a new comprehensive review of these patients. They should do new

x-ray pictures of Trident cup components and assess the placement of

the components. They should also evaluate the occurrence of squeak

sounds and the possible relation of the squeaks to the looming

failure of the cup.

There are many patients bearing Trident cup component in their

artificial hips. These patients are anxious about the fate of just

their Trident cup; Stryker Company has the ethical obligation to

still the anxiety of these patients.

According to the information recently published by Dept of Justice;

Stryker paid 27 million $$ to doctors working for the Company. Some

of the money was probably paid also for the development of the

Trident cup component. There is thus all reason to finance this

second study of the Trident cup components.

On the other hand, we should be reasonable. FDA issues several

warning letters annually to different companies; only seldom is the

fault of the product so big that the product is retracted from the

market. The idea behind the Trident ceramic cup is great and it will

work if the manufacturing process would follow the Current Good

Manufacturing Practice.

____________________________

References:

.. D' JA et al.: A titanium-encased alumina ceramic bearing

for total hip arthroplasty: 3- to 5-year results. Clin Orthop Relat

Res. 2005 Dec;441:151-8

A. J. Langdown, et al: Incomplete seating of the liner with the

Trident acetabular system, A CAUSE FOR CONCERN? Journal of Bone and

Joint Surgery 2007 - British Volume, Vol 89-B, 291-295.

---------------------------------------------------------------------

-----------

>

>

> " U.S. regulators have warned medical device maker Stryker Corp

about

> manufacturing problems linked to some malfunctioning hip implant

parts.

>

> At times, the malfunctions were serious enough to require

additional

> surgery to fix the problems.

>

> A copy of a warning letter sent to Stryker was posted on the U.S.

Food

> and Drug Administration Web site on Tuesday. It said infractions at

> the company's Mahwah, New Jersey, plant included failure to fix

> quality problems, including those related to its Trident

> hip-replacement systems. The 11-page letter was dated Nov. 28. "

>

> Check story in the boston globe

>

> http://tinyurl.com/2ah4nr

>

> Aussie Margaret

>

[Guest guest]

I had this implant used in my 9/2006 surgery. The femoral component

failed and it had to be redone in 7/2007. It was redone with a DePuy

and it healed fine.

> STRYKER'S CERAMIC HIP TRIDENT RECEIVED WARNING FROM FDA

>

> The second biggest manufacturer of artificial hip joints, Stryker,

> got a warning from the USA agency for the defective quality of

total

> hip devices produced by the Company.

>

> In the letter that was published on Agency's Webbsite January 17,

> the Agency points specifically to the defects of the Company's

> ceramic cup component TridentTM. (Click here for picture of the

> Trident cup. It is the upper picture)

>

> There were ongoing complaints that this cup is difficult to

assemble

> and to anchor stably in the patient's skeleton since 2005.

Moreover,

> the patients complained about noises from these cups, the noises

> that sometimes heralded looming failures. The Agency states that

> Stryker Company " had failed to correct the identified faults " .

> Several letters were namely sent by the Agency during 2007 urging

> the Company to correct the manufacturing faults that led to the

> reported failures of the Trident component.

>

> Interesting reading that evokes some questions:

>

> First, the letter contains no data about the number / percentages

of

> the Trident cup failures. How big is the problem really?

>

> Second, the timing of the Warning letter. It was sent on Nov 28,

> 2007, yet it was published on Agency's Webbside almost two months

> later (January 17). Why this delay?

>

> Third, the Warning Letter speaks about the failure of the Trident

> ceramic cup leading to new operation (revision). How much was

> published about it in the scientific journals?

>

> Practically nothing. The Trident cup is a complicated construction,

> consisting of three layers (See Ceramic Total hips). It was

> introduced as " The right implant for the right performance " .

>

> Surgeons working for Stryker published a report in 2005 about the

> Trident component. Six USA surgeons followed 316 patients who were

> operated on with the Trident cup. Three to five years after surgery

> these surgeons noted that in these patients the ceramic in-liners

> remained intact during this period. The surgeons

concluded " Encasing

> the alumina ceramic insert in a titanium sleeve seems to have

> resolved the issue of insert chipping on impaction and supports the

> continued use of Trident bearings in relatively young patients " .

>

> In March 2007 independent British surgeons published a report that

> came to completely different conclusion. They found that it is

> difficult to place properly this Trident cup. (Click here for a

> report about this article). The British surgeons suspected that the

> difficulty to place the Trident cup properly is caused by the

> fact " that the Trident shell deforms upon implantation, thereby

> preventing complete seating of the liner " . And they conclude " We

> have identified a potential problem with the Trident ace-tabular

> shell when used in combination with its metal-backed ceramic liner " .

>

> The FDA letter, however, offers another more probable explanation

> of " this potential problem. The " adulterated methods used for

> manufacturing of Trident cup " are producing components with wrong

> dimensions, incompatible with each other. It is then impossible to

> assemble properly the Trident's three cups together. Because these

> cups are recommended for use in young patients so that these

Trident

> cup are supposed to stay in place several years, this is a serious

> fault.

>

> Information for you: It is always difficult to explain why the

> doctors working for the manufacturing company find better results

> for the products already on market than independent surgeons. The

> suspicion that company's surgeons are forbidden to publish bad

> results, often presented in lay press, is not much probable. If the

> product is already on the market, the bad characteristics of the

> product cannot be kept secret.

>

> In my opinion Stryker Company should finance the American surgeons

> (doctors D' and colleagues) who authored the 2005 article to

> do a new comprehensive review of these patients. They should do new

> x-ray pictures of Trident cup components and assess the placement

of

> the components. They should also evaluate the occurrence of squeak

> sounds and the possible relation of the squeaks to the looming

> failure of the cup.

>

> There are many patients bearing Trident cup component in their

> artificial hips. These patients are anxious about the fate of just

> their Trident cup; Stryker Company has the ethical obligation to

> still the anxiety of these patients.

>

> According to the information recently published by Dept of Justice;

> Stryker paid 27 million $$ to doctors working for the Company. Some

> of the money was probably paid also for the development of the

> Trident cup component. There is thus all reason to finance this

> second study of the Trident cup components.

>

> On the other hand, we should be reasonable. FDA issues several

> warning letters annually to different companies; only seldom is the

> fault of the product so big that the product is retracted from the

> market. The idea behind the Trident ceramic cup is great and it

will

> work if the manufacturing process would follow the Current Good

> Manufacturing Practice.

>

> ____________________________

>

> References:

>

> . D' JA et al.: A titanium-encased alumina ceramic bearing

> for total hip arthroplasty: 3- to 5-year results. Clin Orthop Relat

> Res. 2005 Dec;441:151-8

>

> A. J. Langdown, et al: Incomplete seating of the liner with the

> Trident acetabular system, A CAUSE FOR CONCERN? Journal of Bone and

> Joint Surgery 2007 - British Volume, Vol 89-B, 291-295.

>

>

>

>

>

> --------------------------------------------------------------------

-

> -----------

>

> >

> >

> > " U.S. regulators have warned medical device maker Stryker Corp

> about

> > manufacturing problems linked to some malfunctioning hip implant

> parts.

> >

> > At times, the malfunctions were serious enough to require

> additional

> > surgery to fix the problems.

> >

> > A copy of a warning letter sent to Stryker was posted on the U.S.

> Food

> > and Drug Administration Web site on Tuesday. It said infractions

at

> > the company's Mahwah, New Jersey, plant included failure to fix

> > quality problems, including those related to its Trident

> > hip-replacement systems. The 11-page letter was dated Nov. 28. "

> >

> > Check story in the boston globe

> >

> > http://tinyurl.com/2ah4nr

> >

> > Aussie Margaret

> >

>