Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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Patient Problems
Pain (1994); Joint Dislocation (2374)
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Event Date 07/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source, foreign ¿ event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported a patient underwent a knee revision approximately seven months post-implantation due to pain, clicking, dislocation, and suspected loosening.The bearing was removed and replaced.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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