Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Numbness (2415); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: ep-189042 - e1 vngd as tib brg 12x67 - 915460; 183026 - vanguard cr ilok fem-lt 62.5 - 975920; 141232 - biomet cc cruciate tray 67mm - j3234264.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event: 0001825034-2023-00984; 0001825034-2023-00985; 0001825034-2023-00986.
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Event Description
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It was reported a patient underwent an initial left knee arthroplasty.Subsequently, nine years later, the patient reports they have experienced pain, swelling, and numbness since having surgery.Attempts have been made and no further information has been provided.
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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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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.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot 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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