Catalog Number 183422 |
Device Problem
Unstable (1667)
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Patient Problems
Pain (1994); Joint Laxity (4526); Unequal Limb Length (4534); Swelling/ Edema (4577)
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Event Date 05/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical product: vanguard cr ilok fem-lt 60 60: catalog#183024, lot#247590; bmet arcom ap pat w/wire 31mm ire 31mm: catalog#11-150826, lot#453550; biomet ilok pri tib tray 63mm: catalog#141211, lot#480960; biomet finned pri stem 40mm: catalog#141314, lot#843360.Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2022-01120; 0001825034-2022-01121; 0001825034-2022-01122; 0001825034-2022-01123.Customer has indicated that the product will not be returned to zimmer biomet for evaluation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient underwent an initial left total knee arthroplasty.Subsequently, the patient states to have persistent pain for the past eight years and seven months post implantation.The patient also experiences swelling in the knee with weather changes and states that the left leg has been longer than the right since the surgery.Instability was noted upon assessment and the patient underwent bone scans and lab work to determine eligibility for revision.Final outcome is pending at this time.
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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 is complete, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient underwent an initial left total knee arthroplasty.Subsequently, the patient has experienced persistent pain, swelling in the knee with weather changes, and states that the left leg has been longer than the right since implantation.Instability was noted upon assessment and the patient underwent bone scans and lab work to determine eligibility for revision.Approximately nine years and nine months post implantation, the patient underwent revision surgery due to pain, swelling, and loosening.No further information has been made available at the time of this report.
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Event Description
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No further event information at time of this report.
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Manufacturer Narrative
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Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records provided state that the patient was experiencing pain and instability.X-ray review by third party states that the x-rays demonstrate bilateral total knee arthroplasty without radiolucency to suggest loosening.No fracture or no significant joint effusion was seen.Root cause was unable to 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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