Model Number N/A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Pain (1994)
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Event Date 01/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00114, 3002806535-2019-00115.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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Knee revision due to pain and loosening.
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Event Description
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Knee revision due to pain and loosening.
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Manufacturer Narrative
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(b)(4).The radiological materials were provided by the hospital, however, due to the sub-optimal quality of the images, detailed analysis of the implants was not possible.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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