Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Scar Tissue (2060); No Information (3190)
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Event Date 05/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 a patient was revised due to an unknown reason.
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Manufacturer Narrative
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(b)(4).Device history record (dhr) was reviewed and no discrepancies were found.
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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.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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Event Description
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The reason for the revision was scar tissue debridement and surgeon decided to swap the bearing during the procedure.
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Search Alerts/Recalls
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