SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Catalog Number 71337652 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Injury (2348)
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Event Date 01/15/2019 |
Event Type
Injury
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Event Description
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It was reported that a revision surgery was performed due to a dislocation and metallosis.
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Manufacturer Narrative
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Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that revision surgery was performed due to the shell, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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