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Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Unstable (1667)
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Patient Problems
Inflammation (1932); Pain (1994); Swelling (2091)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Unique identifier (udi) # - (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00854, 3002806535-2017-00855.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 has been indicated for knee revision approximately 10 months post-implantation due to pain, instability, inflammation, swelling, component loosening, and "defective" cement.No revision procedure has been reported.
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Manufacturer Narrative
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(b)(4).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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