(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.Concomitant medical devices: part: 802202802, lot: 64913231, zb 12/14 cocr hd 28mm x +0; part: 00500105100, lot: 64485255, shell 51 mm o.D.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00297, 0002648920-2021-00298.
|
It was reported that a patient underwent a hip arthroplasty subsequently, 7 months later the patient is being considered for a revision due to pain.Patient currently has a partial hip and will transition to total hip.Only cup, liner and head to be revised.Attempts have been made and no further information has been provided.
|