SMITH & NEPHEW, INC. HIP HEAD IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Device Problem
Degraded (1153)
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Patient Problem
Injury (2348)
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Event Date 10/13/2018 |
Event Type
Injury
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Event Description
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It was reported that a revision surgery was performed due to wear and osteolysis.The primary operation was more than 25 years ago.Stem retained.Removed head, liner and optifix shell.
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Manufacturer Narrative
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The associated complaint devices were not returned for evaluation.Our clinical evaluation noted no additional clinical documents are available at this time.Therefore, no thorough clinical assessment of the reported issue can be rendered.Without the return of the actual product involved and no product information available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
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Search Alerts/Recalls
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