(b)(4).Mäkinen, t.J., abolghasemian, m., watts, e.Fichman, s.G., kuzyk, p.Safir, o.A.& gross, a.E.(1 may 2017) management of massive acetabular bone defects in revision arthroplasty of the hip using a reconstruction cage and porous metal augment.The bone & joint journal, vol.99-b, no.5, pages 607-613.Https://doi.Org/10.1302/0301-620x.99b5.Bjj-2014-0264.R3.Concomitant medical products: unknown acetabular cage, catalog #: ni, lot #: ni.Report source - foreign: (b)(6).The product could not be evaluated and the reported event was not confirmed.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information provided.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.[management of massic acetabular bone defects.Pdf].
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It is reported that a patient developed fracture of the iliac flange, migration of the augment and a leg-length discrepancy approximately twenty-two (22) months following structural allograft reconstruction.No medical intervention was required, as the patient was asymptomatic.Attempts have been made and no additional information is available.
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