STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Model Number 1236-2-848 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 03/14/2022 |
Event Type
Injury
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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.
The following devices were also listed in this report: modular dual mobility insert; cat#626-00-42e ; lot#73068904.
Primary secur-fit plus max #8/14; cat#6054-0814s ; lot#ha6axa.
Delta c-taper head 28mm +5; cat#18-2805 ; lot#72455401.
Tridentii tritanium solid 52e; cat#700-04-52e; lot#71575501a.
It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Event Description
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Pt experiencing pain in right hip.
Revision total hip.
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Search Alerts/Recalls
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