Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
No Information (3190)
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Event Date 05/28/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: patell item # unknown lot 3 unknown, art surface item # 42522400711 lot # 63119959, femur item # 42500606402 lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the hospital will no permit.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 a patient underwent an initial knee procedure; subsequently 30 months later the patient was revised due to loosening.Presumed loosening of tibial component.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records for the initial surgery identified no intra op complications.Op notes for the revision surgery were not provided.Per persona the personalized knee system package insert, loosening is a known potential adverse effect of this procedure.However, a definitive root cause cannot be determined, as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental 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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