(b)(4).Concomitant medical products: persona femur cemented posterior stabilized (ps), catalog # 42500605802, lot # 63982839; persona stemmed tibia, catalog # 42532006702, lot # 64078277; persona all poly patella, catalog # 42540000029, lot # 64214476.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2019-00069, 3007963827-2019-00070, 0002648920-2019-00193.Remains implanted.
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It was reported that the patient underwent a right knee arthroplasty.Subsequently, the patient was experiencing deep vein thrombosis one month post operative.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.
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Reported event was confirmed by review of medical records.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of available medical records indicates there is no complication during the primary surgery and patient experienced dvt after surgery.Per the health care professional, dvt is a procedure-related event and is not implant related.Therefore, no failure detected related to the implant.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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