STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER48D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
|
Back to Search Results |
|
Model Number 702-04-48D |
Device Problem
Loss of Osseointegration (2408)
|
Patient Problem
Inadequate Osseointegration (2646)
|
Event Date 02/14/2023 |
Event Type
Injury
|
Event Description
|
Revision total right hip due to loosening and migration of acetabular shell.Replaced shell, liner, poly head and metal femoral head with different manufacturer products.Per response: operative side was - "right side".
|
|
Manufacturer Narrative
|
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.
|
|
Search Alerts/Recalls
|
|
|