STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Model Number 1236-2-852 |
Device Problem
Unstable (1667)
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Patient Problem
Joint Laxity (4526)
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Event Date 06/22/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient's right hip was revised due to instability.An adm/ mdm poly insert, mdm metal liner, ceramic head and sleeve and 2 screws were revised to a constrained liner and new femoral head.Rep confirmed that intra-operatively no implants were noted to be worn, loose, or damaged.
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Manufacturer Narrative
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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.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.Device not returned to the manufacturer.
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Search Alerts/Recalls
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