Catalog Number 32810502704 |
Device Problems
Unstable (1667); Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); Joint Laxity (4526)
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Event Date 11/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 32810504302 interchangeable ulnar assembly plasma sprayed extra small right 3 inch length 64363467.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.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 - 2020 - 03910.
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Event Description
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It was reported that the initial right total elbow arthroplasty was performed.Subsequently, the patient was revised due to separation of the joint axis pin.No additional patient consequences were reported.
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Event Description
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It was reported that the patient was revised due to elbow instability and separation of the joint axis pin.Further, the postoperative radiograph shows intraprosthetic loosening of the elbow prosthesis.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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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No additional event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The device was returned and the device was assembled and locked together.After the device was disassembled, the damage was seen on the inner pin during visual examination.The device was disassembled and reassembled, indicating they function as intended.Device history record (dhr) was reviewed and no discrepancies were found.Medical records/radiographs were provided and reviewed.Review of the available records identified the following: primary op notes were reviewed and no complications were noted.Medical notes identified: problem with the medical device: early revision surgery of the axis in a total elbow prosthesis because of dislocation/disassociation of the axis.Axis has deserted, probably badly snapped during the initial operation.Radiographs were reviewed and identified interval displacement of the elbow arthroplasty joint axis pin.Root cause was unable to be determined.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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