(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.Unique identifier (udi) #: n/a.Concomitant medical products: 42512200510, articular surface fixed bearing, lot # 63880311; 42532007101, natural tibia, lot # 63895745; 42540000029, all poly patella, lot # 63890774; 42502606401, femur, lot # 63590448; 42509902525, 2.5 mm hex screw, lot # 64038534, quantity x2.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00278, 3007963827-2019-00279, 0002648920-2019-00714, 3007963827-2019-00279, 0001822565-2019-04192, 0001822565-2019-04193.
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It was reported that approximately 1 year post implantation, the patient has been experiencing pain, loss of mobility, and device loosening.Attempts have been made and no further information has been provided.
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