SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Device Problem
Device Dislodged or Dislocated (2923)
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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 patient suffer a dislocation on (b)(6) 2012 and 2 days later had a second dislocation.
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Manufacturer Narrative
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The associated complaint devices were not returned.The clinical/medical team concluded, the patients significant weight loss, past surgical history, and deconditioning from limited mobility in the presence of bending over and rising from a couch were all likely contributing factors to the recurrent dislocations and subsequent revision tha.The patient impact beyond the dislocations/closed reductions, pain and subsequent revision cannot be determined.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
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Search Alerts/Recalls
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