SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 46MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Model Number 71331946 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Injury (2348); Joint Dislocation (2374)
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Event Date 09/24/2018 |
Event Type
Injury
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Event Description
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It was reported that oxinium femoral head was revised due to patient was non compliant with post operative precautions, then had recurrent dislocations of hip.
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Manufacturer Narrative
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The associated complaint devices were not returned.A clinical analysis indicated that it was reported that the patient was non-compliant with post op precautions and had recurrent dislocations of hip.A revision right thr was performed three months post op.No clinical relevant supporting documents were provided to conduct a thorough medical assessment of the reported hip dislocation.Without the surgical findings, medical documents, x-rays, or explants for analysis the root cause of the reported dislocations cannot be definitively concluded.However, the patient¿s reported non-compliance with post-op precautions is likely a contributory factor.The future impact to the patient cannot be determined.Based on the information provided no further clinical assessment is warranted at this time.Should additional information be provided, the clinical/medical investigation task will be reopened.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed parts did not reveal additional complaints for the listed batches.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
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Event Description
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It was reported that revision surgery was performed due to recurrent dislocations of hip since the patient was non compliant with post operative precautions.Surgeon decided to revise with competitor cup.
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Search Alerts/Recalls
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