(b)(4).D10: medical products: item#: unknown, unknown glenoid, lot#: unknown; item#: unknown, unknown central screw, lot#: unknown; item#: unknown, unknown peripheral screw, lot#: unknown; item#: unknown, unknown peripheral screw, lot#: unknown; item#: unknown, unknown peripheral screw, lot#: unknown.H3: customer has indicated, that the product will not be returned to zimmer biomet for investigation, as the product remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported, that the patient underwent an initial left shoulder arthroplasty on and unknown date.Subsequently, the patient is being considered for a revision surgery, due to glenoid bone loss that has caused the patient pain.And possible loosening of implants.Multiple attempts have been made for additional information, but no additional information has been received at this time.
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