(b)(4).Concomitant medical products: m2a-magnum mod hd sz 52mm, pn 157452, ln 101240.M2a-magnum 52-60mm tpr insrt-3, pn 139266, ln 068770.M2a-magnum pf cup 58odx52id, pn us157858, ln 722540.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00101-1, 0001825034-2020-00102-1, 0001825034-2020-00103-1.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. the investigation is in process. once the investigation has been completed, a follow-up mdr will be submitted.
|
Primary right tha performed.Patient subsequently developed elevated metal ions and noise.Attempted revision procedure occurred 9 years later, and unable to disengage femoral head, surgical procedure was aborted and surgical site was irrigated and closed.Approximately 1 week post aborted procedure, patient developed fever and superficial surgical site infection.I&d of surgical site performed 9 days later, no components removed.Patient received iv antibiotic treatment.
|