STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ2 LEFT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5512-F-201 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Injury (2348); Inadequate Osseointegration (2646)
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Event Date 09/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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It was reported the patient's left knee was revised due to femoral loosening.The femoral component with stem, 3 augments, and liner were revised to another femoral component with stem, 3 augments and a liner.Rep confirmed there are no allegations against the liner.Rep provided primary and revision usage and reported that no further information will be available.
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Search Alerts/Recalls
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