(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2021-03175, 3007963827-2021-00267, 3007963827-2021-00268, 3007963827-2021-00269, 0001822565-2021-03176, 0001822565-2021-03177.Concomitant medical products: femur cemented (cr) standard nitrided right size 7, item# 42572606202, lot# 64858067 articular surface (mc) right 12 mm height, item# 42522100412, lot# 64250680 articular surface (mc) right 11 mm height , item# 42522100411, lot# 64444760 tibia cemented 5 degree stemmed right size d, item# 42532006702, lot# 64765324 headed screw 48 mm length, item# 00579104100, lot# 64249523; headed screw 48 mm length, item# 00579104100, lot# 64810228.Device evaluated by mfr: customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that a patient is experiencing pain, inflammation, and has had a high white blood cell count since she had an initial right knee arthroplasty.The patient stated that the surgeon told her that he gave her a different size because there was not an option available in her size because she is a smaller person.Patient also stated that she is allergic to nickel.Attempts to obtain additional information have been made; however, no more information is available at this time.
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