Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526)
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Event Date 08/25/2023 |
Event Type
Injury
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Event Description
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It was reported initial that the patient underwent left unicompartmental knee arthroplasty.Approximately 2 years later, the patient reported pain, noise and instability with occasional sensation of giving away in the popliteal area and falls, no intervention provided, x-rays revealed the components to be in excellent position.A revision surgery was performed due to polyethylene dislocation and acl failure resulting in instability.During the revision noted acl deficit that caused the instability.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).D10/d11: concomitant medical products ¿ medical devices: oxf anat brg lt sm size 5 pma, item# 159542, lot# 865400.Oxf uni tib tray szalm, item# 154718, lot# 154718.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00303, 3002806535 - 2023 - 00305.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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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were provided and reviewed by a health care professional/radiologist.The review identified the following: was getting in a recliner, felt a pop in her knee and her knee locked.X-ray: mobile bearing polyethylene component dislocated it flipped into the suprapatellar pouch.Failed left uka with dislocated polyethylene and acl failure resulting in instability.Spinal anesthesia.Previous incision utilized.Components removed with minimal bone loss.Acl was deficient and likely instability of the knee led to her polyethylene dislocation.No complications.Radiographs were provided and not reviewed as the medical records dictate the findings.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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Search Alerts/Recalls
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