STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRITANIUM ACETABULAR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
|
Back to Search Results |
|
Catalog Number UNK_JR |
Device Problem
Osseointegration Problem (3003)
|
Patient Problems
Pain (1994); Injury (2348)
|
Event Date 04/02/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
|
|
Event Description
|
It was reported through the filing of a lawsuit that allegedly the patient was implanted with a tritanium acetabular cup in his right hip on (b)(6) 2014 and in light of worsening symptoms he was taken back for revision surgery to his right hip on (b)(6) 2019.It is further alleged "prior to surgery, it was discovered that he had persistent pain in his right hip after the initial operation, and subsequent workup demonstrated circumferential radiolucency around the acetabular component and aseptic loosening of the acetabular component.During his revision surgery, the cup was found to be grossly loose, with only a rim of bone intact.".
|
|
Search Alerts/Recalls
|
|
|