(b)(4).Source: (b)(6).Concomitant medical devices: catalog number:11-300816 lot number: 796550; catalog number:22-301112 lot number:013410; unknown head; unknown liner; unknown cup.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02092, 0001825034-2020-02093, 0001825034-2020-02094, 0001825034-2020-02095.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in the patient.
|