(b)(4).Age or date of birth: unknown day in (b)(6).Concomitant medical products: catalog#: 00877704404 bioloxâ® option, head, xl, 㸠44/+7, taper 12/14 lot#: 2692724.Catalog#: 0100551310 fitmoreâ®, hip stem, uncemented, offset b (extended)/10, taper 12/14 lot#: 2649759.Report source: foreign: (b)(4).The device will not be returned for analysis as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
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The event was confirmed with medical records received.Review of the available records identified: the patient underwent a left tha due to oa; no intraoperative complications were noted.The acetabular inclination and anteversion angles were measured at 34 degrees and 16 degrees respectively.During the patient's seven year post op visit, supraacetabular cavity osteolysis was confirmed by ct.The patient is completely asymptomatic and satisfied with the result of the surgery.The acetabular inclination and anteversion angles remain unchanged.Periprosthetic radiolucency affecting the femoral and acetabular component in relation to prosthetic mobilization.Osteolysis area of 47x25 mm in acetabular wall.No joint effusion.Mri results identified: periprosthetic osteolysis; findings are compatible with granulomatous reaction/fluid reactive synovitis.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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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