(b)(4).This event was previously sent under mfr 0001822565-2019-02435.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00197 and 3007963827-2019-00198.Concomitant medical products: tibia cemented 5 degree stemmed right size d, catalog #: 42532006702, lot #: 64037588.Articular surface medial congruent (mc) right 10 mm, catalog #: 42522100410, lot #: 6399312.All poly patella cemented 32 mm diameter, catalog #: 42540000032, lot #: 64144256.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.
|
It was reported that patient underwent total knee arthroplasty.Subsequently, patient is complaining of pain, swelling, alteration in body temperature, and possible metal allergies.No revision procedure has been reported.
|