Model Number N/A |
Device Problem
Naturally Worn (2988)
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Patient Problem
Failure of Implant (1924)
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Event Date 04/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: item# 211250; lot# 142530; comp srs disc 50mm dst bdy lt; item# 114700; lot# 643330; disc condyle kit w/ hexalobula; item# 211269; lot# 666460; compr srs small flange.Foreign: event occurred in (b)(6).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.Product not returned.
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Event Description
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It was reported that the patient was revised due to bearing wear.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the bearing as being worn.Device not returned.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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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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Search Alerts/Recalls
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