(b)(4).No clinical records, images, or devices were returned for review.The patient¿s medical condition can lead to pain in the joints due to easy bruising and hyperextension.As no additional records have been provided, the diagnosis alone cannot rule out the device as the cause of the pain in this patient and does not account for the additional allegations.A review of the device history records did not identify any deviations or anomalies during manufacturing related to the reported event.A 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.Concomitant medical products: 01-220-12361, proxilock ti ha stem, 12mm, lot unknown.01-100-28002, head superpolish 28mm od +0 nl, lot unknown.00630504828, liner standard 28 mm i.D.For use with 48 mm o.D.Shell, lot 69078700.
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It was reported that approximately 17 years post implantation, the patient is experiencing pain.It was also reported that x-rays identified osteolysis.Patient has also had allegations of increased memory issues, incomplete sentences, and speech problems.Attempts have been made and no further information has been provided.
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