Model Number N/A |
Device Problems
Fracture (1260); Unstable (1667)
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Patient Problems
Failure of Implant (1924); Pain (1994)
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Event Date 07/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D6a: 2019.Report source foreign - australia.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02102.
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Event Description
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It was reported that the patient underwent a revision approximately 4 years post implantation due to instability and pain.After opening the joint, the patella implant appeared to be fractured.This was resurfaced with a larger patella.The poly was exchanged for a thicker option to stabilize the knee joint.It was reported that wear was noted on the poly post and medial/lateral wells.Attempts have been made and no further information has been provided.
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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 patella implant as fractured.The articular surface was identified as worn with nicks and gouges on the post and distal surface.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found 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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