(b)(4).Concomitant medical products: ext-bf shoulder anatomic/primary unk-glenoid component lot#unk item#unk, ext-bf shoulder anatomic/ primary unk-stem lot# unk item# unk.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) review was unable to be performed as the lot number of the device involved in the event is unknown.The compatibility check and complaint history search were not performed.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03369, 0001822565-2018-00806.
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It is reported that the patient underwent shoulder arthroplasty revision due to an adverse reaction that the patient was experiencing, including pain and bone deterioration, to the implants.The surgeon opted to treat the case with a temporary cement spacer.The surgeon plans to further treat the patient with custom implants on a later date.No additional patient consequences are reported.
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