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); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 42500006202 - femur cemented posterior stabilized (ps) narrow right size 7 - 63840636.42532006402 - tibia cemented 5 degree stemmed right size c - 64682011.42540000032 - all poly patella cemented 32 mm diameter - 65270953.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, please see associated reports: 3007963827-2023-00158.3007963827-2023-00159.0002648920-2023-00114.
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Event Description
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It was reported by the patient that they underwent an initial right knee arthroplasty.Subsequently, the patient reports pain and swelling and that they cannot bend their knee well.The patient also has a baker's cyst on the back of the knee that started about 4 weeks post-op and has been prescribed antibiotics on and off since.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 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.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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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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