It was reported that the patient underwent a right total hip arthroplasty.Subsequently, on an unknown date, patient started to experience pain, difficulty walking and trouble sleeping for long periods of time.No plan for revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
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(b)(4).Concomitant medical products: cat #: 136536320, j&j delta-head ceramic, lot #: 8759257, cat #: 157011150, j&j stem, summit, lot #: hp3561, cat #: 010000859, g7 neutral liner, lot #: 6227064.Multiple mdr reports were filed for this event, please see associated reports: liner: 0001825034-2022-02193.The device will not be returned for analysis, due to the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; g3; h2; h3; h4; h6 complaint was confirmed via medical records reviewed by a health care professional.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.It is noted that zimmer biomet products were used in conjunction with a competitor device.Zimmer biomet has not confirmed the compatibility of the reported combination of devices, and these would be considered off-label usages.However, it cannot be confirmed that the combination of the johnson and johnson and zimmer biomet products caused or contributed to the reported event.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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