SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Model Number OR45-DUMMY2 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Injury (2348)
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Event Date 01/01/1901 |
Event Type
Injury
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Event Description
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It was reported that left hip revision surgery was performed due to loosening of the stem.
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Manufacturer Narrative
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The associated complaint device was not returned.The medical investigation concluded that, 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.Without the actual product involved and/ or product information, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.
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