(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 - 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.This complaint has been reassessed as part of ca-(b)(4).It was determined that additional regulatory reporting is required.
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It is reported that one patient developed heterotopic ossification with limitation of movement following hip reconstruction.The patient is awaiting exploration and excision.Attempts were made to obtain additional information, however, no additional information is available.
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