Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Information (3190)
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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 that the patient had an initial right elbow arthroplasty.Subsequently, the pmi group is requesting a small size (4 cm) kudo elbow for a scheduled revision due to loosening.
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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.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.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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