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
Unstable (1667)
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Patient Problem
Injury (2348)
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Event Date 07/02/2019 |
Event Type
Injury
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Event Description
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It was reported that a revision surgery was performed to correct and unstable total hip replacement and converted to r3 constrained liner.No additional details provided.
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Manufacturer Narrative
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The associated complaint devices were not returned.A clinical evaluation was conducted and it has been communicated that no clinical documents are available.Therefore, no thorough clinical assessment of the reported issue can be rendered.Should additional information be provided, the clinical/medical investigation task will be reopened.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.
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