SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Event Description
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It was reported that revision surgery was performed due to loosening of the stem.
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Manufacturer Narrative
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The device, intended for use in treatment, was not returned for evaluation.A clinical evaluation was conducted and without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file.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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Search Alerts/Recalls
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