Stryker Hip Implant Replacement Recall
Trident PSL and Hemispherical Acetabular Cups were recalled by Stryker as it had failed to maintain manufacturing procedures conforming to the FDA guidelines. The FDA warned Stryker that its product was not worth use of patients requiring hip implant surgery.
On January 22, 2008, Stryker announced that it was recalling two products within the company’s Trident line. The Stryker Hip Implant component recall involves two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Neither of these recalls is directly related to the issues discovered at the New Jersey plant, which could result in even more investigation into this problem
Stryker Hip Implant Problems and Recall:The first sign of trouble for these Stryker products surfaced in January of 2005, when reports of multiple complaints by consumers using the product began to hit the news. These complaints consisted of several serious problems, including extreme pain in the surgical area, squeaky joints, the tendency for parts of the implant to break off and/or wear down unevenly, creating extreme pain and discomfort, and finally and perhaps most seriously, improper fittings of these implants that ultimately led to bone fractures in the patients’ bodies.
FDA Investigation of Stryker Hip Implants
During the summer of 2007, the FDA spent six weeks inspecting Stryker’s manufacturing facility in Mahwah, New Jersey, and as a result compiled a list of problems. Included among them were deficiencies in the quality control stages of manufacturing and the presence of disease-causing germs, including "clumps and clusters" of a form of Staphylococcus bacteria.
Timeline Of Events And FDA Warnings To StrykerFebruary 3, 2003: FDA approves Stryker’s Trident hip replacement system.
January 2005 to April 2007: Stryker receives a large number of complaints from patients about their Trident hip implants, yet takes no significant action.
March 15, 2007: FDA sends a warning letter to Stryker over defecting practices in its Ireland manufacturing facility. “This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation.”
November 28, 2007: FDA sends a second warning letter to Stryker. “[C]ustomer complaints have been received for squeaking/noisy ceramic on ceramic hip joints.”
January 22, 2008: Under pressure from the FDA, Stryker initiates a voluntary recall. “As a result of the deviation from internal specifications, the Company is initiating a voluntary recall of Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork facility.”
What Is The Status Of The Hip Implant Litigation?