STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ6 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
|
Back to Search Results |
|
Catalog Number 5512-F-602 |
Device Problem
Osseointegration Problem (3003)
|
Patient Problems
Injury (2348); Inadequate Osseointegration (2646)
|
Event Date 07/29/2019 |
Event Type
Injury
|
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.Device not returned.
|
|
Event Description
|
It was reported that the patient's right knee was revised due to femoral component loosening.The patient's entire knee construct (femoral component, stem, augments, insert, tibial baseplate with stem) were revised to a distal femoral replacement due to the patient's poor bone quality.No allegations against the tibial baseplate or liner were reported to the rep.Rep reported that the hospital and surgeon will not release any further information.
|
|
Search Alerts/Recalls
|
|
|