Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032)
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Event Date 10/11/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 medical devices: oxford uni twin-peg femoral md; item# 166942; lot# j3834742; oxf anat brg lt md size 4 pma; item# 159548; lot# 3860787; g2 ¿ foreign: australia; multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00374; 3002806535 - 2023 - 00376; 3002806535 - 2023 - 00377.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the patient underwent a uni knee surgery, and approximately six years later, revision surgery was performed due to pain and stiffness.The patient experienced ongoing pain and a limited range of motion around 12 months post-op.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.The review identified the two views of the left knee demonstrate a medial compartment hemiarthroplasty without hardware failure or loosening.No bony fracture.Overall fit and alignment of the implant is appropriate.Normal bone quality.With the available information, a definitive root cause could not 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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