(b)(4).Concomitant medical products: 113764 bio-mod hum head 44diax17mm unknown, 113575 comp fx hum pos sleeve 7mm unknown, 414994 small dia cement plug 10mm unknown, unknown stryker implex cement.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, hospital policy.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: 0001825034 - 2019 - 01654.
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It was reported that patient under went an initial shoulder hemiarthroplasty for a fractured shoulder and was subsequently revised due to pain, reduced range of motion due to non union, loosening and tendon tear one (1) year six (6) months post primary implantation.Surgeon noted superior glenoid wear and original fracture did not heal from the primary surgery.No additional information is available from the event.
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