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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling (2091); Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs: kne-unknown-tibial- mdr: 0001822565-2021-00254.
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Event Description
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It was reported that patient underwent left total knee arthroplasty.Subsequently, approximately three years and two months post procedure, the patient experiences pain/discomfort, swelling, tightness and found she has metal sensitivity to nickel.
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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.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.This complaint cannot be confirmed.A definitive root cause cannot be determined with the information provided no corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products and mdrs knee-unknown-bearing-unknown mdr: 0001822565-2021-00433.
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Search Alerts/Recalls
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