(b)(4).Concomitant medical products: modular femoral stem press-fit plasma sprayed cementless size 10 cat: 00771301000 lot: 61813586, femoral head cat: 00801803602 lot: 61841705, liner standard 3.5 mm offset 36 mm i.D cat; 00630505036 lot: 61796239, shell porous with cluster holes 54 mm o.D.Cat: 00620005422 lot: 61809032.Reported event was confirmed by review of medical records.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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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It was reported that the patient was revised due to pain, loosening, periprosthetic fracture, elevated metal ion levels, comorbidities, hematoma, necrosis, in vivo corrosion, heterotopic ossification, difficulty ambulating, decrease in adls, pseudotumor, failure to osseointegrate, osteolysis, dislocation, adverse local tissue reaction, and instability.No additional patient consequences were reported.Attempts have been made and no further information has been provided.
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