Stryker Recalls Hip Implant Kits
On November 28, 2007, Stryker Corp., a leading maker of hip replacements and other joint replacement components, received a warning letter from the Food & Drug Administration (FDA) regarding deficient and unsanitary conditions at the Stryker manufacturing facility in Mahwah, New Jersey. The FDA warning letter resulted from an inspection of the Stryker plant that occurred in the summer of 2007, and marked the second time the FDA had told Stryker to correct the deplorable conditions at the New Jersey manufacturing facility.
In responding to the FDA warning letter, Stryker maintained that it "did not believe there is any clinical evidence to indicate that the products mentioned in the Warning Letter present a safety issue to patients." However, the FDA warning letter had stated that Stryker had received complaints about hip implant components made at the Mahwah facility dating back to 2005.
Outrageously, in the same press release in which Stryker defended the quality of its products, the company announced a recall of two defective Trident hip implant components. Though they were not made at the plant cited in the FDA warning letter, the recall of the Trident components raised serious questions about the quality controls employed by Stryker.
Some Technical Data on the Stryker Hip Replacement Implant
As the reader may recall, Stryker Hip Replacement Implant has marketed the Trident Acetabular System since 1999. The system features a locking mechanism and several options, including cluster or solid-back shells, hydroxylapatite (HA) coating, alumina ceramic and two different polyethylene bearing surfaces, eccentric and constrained shell geometries, and Tritanium fixation.
Stryker has widely promoted its Trident Ceramic System, especially for younger, more active patients. The company proclaims that "laboratory and clinical data indicate that ceramic bearings may be the most significant advancement in total hip replacement wear performance, helping to reduce wear to near undetectable levels."
The system includes the shell of cup that is implanted into the patient's acetabulum (hip bone); a ceramic insert/titanium sleeve assembly which forms the socket; and a ceramic head or ball. The femoral stem is not shown.
The insert and head of the system are both made of alumina ceramic which, Stryker states, significantly lowers wear compared to conventional plastic-on-metal or metal-on-metal joint systems, at least "in the laboratory."
A shrink-fit titanium sleeve encapsulates the ceramic liner which the manufacturer states increases the material strength of the ceramic insert compared to other ceramic inserts on the market.
Conclusions on the Stryker Hip Replacement Recall
Stryker has had problems with many of their products. There have been longstanding concerns that brittle ceramic material is associated with a higher fracture risk, a "squeak" phenomenon, and potentially a higher dislocation rate secondary to limited neck lengths and liner options. Stryker claims that a study involving 1635 patients have dispelled those concerns.
Yet, orthopedic surgeons examining the products suggest that "there is the distinct possibility that the Trident shell deforms upon implantation, thereby preventing complete seating of the liner."
There is still a significant problem with several hip replacement devices. If you are having trouble with a defective hip implant it is not to late to get legal help. Contact Bisnar Chase right away for a free case evaluation.
