STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number 1236-2-852 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Injury (2348); Joint Dislocation (2374)
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Event Date 11/26/2019 |
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 that the patient's left hip was revised.Patient suffered a disassociation (ceramic femoral head out of the adm/mdm poly insert), was closed reduced, dislocated and disassociated, with the femoral head articulating against the mdm metal liner (poly was both off the femoral head and out of the liner.Patient's poly insert and femoral head were revised.The rep may be able to obtain the explants for return, provided the primary usage sheet, and confirmed that no further information will be available.
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Search Alerts/Recalls
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