Stryker hip implant defects

Stryker orthopedics corp.’s defective hip implants result in revision surgeries for patients according to FDA

Stryker Orhtopedics hip replacements do not meet quality standards and the company has failed to identify and fix problems in both its manufacturing and oversight processes despite a stream of complaints over a two year period, according to the FDA.

FDA Warning Letter

“Your firm has failed to implement adequate corrective and preventive actions in order to prevent recurrence of nonconforming product and other quality problems,”
the FDA said in a warning letter.

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Defective Products

The following Stryker Hip Replacement Devices and other products may have manufacturing defects according to the FDA.

  • Trident PSL Acetabular Shells
  • ReUnion Plasma Spray Humeral Stem
  • Solar Plasma Purefix HA Shoulder Stems
  • Duracon Toatal Knee Modular Femoral Component
  • Global Modular Hip Stems
  • Trident PSL HA Solid Black 52 MM
  • Trident Hemispherical Cluster 50 MM
  • Hip Implant components with ceramic bearing components

SCENARIO

Stryker is a medical-device company generated over $5 billion in sales from its hip, knee and shoulder implants as well as other medical products.
The problems were found by the FDA during an inspections in June and July of 2007 at the company’s manufacturing facility.

In March 2007 independent British surgeons published a report entitiled 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 by A. J. Langdown, et al. They found that it is difficult to place properly the Trident cup. 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”.

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