(b)(4).Common device name: phx.Concomitant medical products: comp rvs cntrl 6.5x25mm st/rst: cat# 115395, lot# 071970; comp lk scr 3.5hex 4.75x30 st: cat# 180553, lot# 420090; comp lk scr 3.5hex 4.75x30 st: cat# 180553, lot# 498970; comp lk scr 3.5hex 4.75x15 st: cat# 180550, lot# 234020; unknown locking screw: cat#ni, lot#ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00539, 0001825034-2022-00540, 0001825034-2022-00541, 0001825034-2022-00542, 0001825034-2022-00543.
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fractured glenosphere screws with loosening of the glenoid component.Possibly related to extensive glenoid heterotopic ossification.Radiolucency surrounding the glenosphere, consistent with loosening.Bony impaction of the humeral component with the heterotopic ossification arising of the inferior aspect of the glenoid.A definitive root cause cannot be determined.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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