Catalog Number UNKNOWN PLATE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Limited Mobility Of The Implanted Joint (2671)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.[(b)(4)].
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Event Description
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The study reported thirteen patients who experienced limited rom postoperatively.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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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