(b)(4).Customer has been 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 07263.
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It was reported that the patient underwent a right shoulder arthroplasty procedure.Subsequently, the patient is experiencing tightness around the humeral head, looseness around the humeral stem, limited range of motion, numbness, and some degree of pain.It was reported the humeral head was too tight and that the ball of the shoulder was too big.The bone scan was inconclusive.Attempts have been made and additional information on the reported event is unavailable.
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