(b)(4).Concomitant products: 113044, comprehensive humeral head, 351910.113954, comprehensive hybrid glenoid, 458020.113044, comprehensive humeral head, 351910.113954, comprehensive hybrid glenoid, 458020.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: 0001825034 - 2017 - 10037.0001825034 - 2017 - 10038.
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(b)(4).The following report is submitted to relay additional information.The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Review of the x-rays identified that there was right shoulder arthroplasty with glenoid component containing a central peg which demonstrates radiolucency along the proximal aspect of the peg.There was no significant radiolucency along the remainder of the central peg.Humeral component appeared to be adequately placed without significant radiolucency.Ossific density along the posterior glenoid on the axillary film may represent a loose body.It was also noted there was mild ac joint degenerative change and osteopenia within the glenoid and proximal humerus.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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