The following devices were also listed in this report: 26mm -3 lfit v40 head; cat # 6260-9-026; lot # 80619806, accolade c cs 132 nk; cat # 6058-0537d; lot # kj1389, accolade distal spacer; cat # 1059-4515; lot # e2591k.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a uhr bipolar head was reported.The event was not confirmed method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinical review: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot and for sterile lot.Conclusion: the event of infection was not confirmed.The root cause could not be determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as pre- and post-op x- rays, pathology report & follow-up notes are needed to investigate this event further.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.If additional information and/or device becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.
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