SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Device Problems
Fracture (1260); Loose or Intermittent Connection (1371)
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Patient Problem
Pain (1994)
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Event Date 01/23/2016 |
Event Type
Injury
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Event Description
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It was reported that on 2017 veralist product failed.Right femur fractured.Device did not adhere to the bone structure, moved, and caused loosening and pain on the left hip.Further information is unknown.A quantity of 5 hip replacements were performed, it is unknown to which hip belongs each one.
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Manufacturer Narrative
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The associated complaint devices were not returned.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.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.We consider this investigation closed.
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