Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Loss of Range of Motion (2032)
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Event Date 02/24/2020 |
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, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical product(s): unknown femoral component; unknown tibial tray.Report source: event occurred in (b)(6).
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Event Description
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It was reported that approximately 9 months post implantation, the patient was revised of the articular surface due to increasing stiffness and limited range of motion.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 and corrected information.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2020-00960, 0001822565-2020-01908.
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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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