Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that neither a lot number nor material number were provided, review of the device quality and manufacturing history records (dhr) could not be performed.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.In this case the product risk analysis is only conditionally applicable, because the area of the axis breakage is unknown.Both types of breakages were considered separately in the risk analysis.Explanation and rationale: according to the surgeon who made the revision surgery, the tibial component was found to be misrotated, off-axis and misaligned.This could be a hint for a usage/patient related error.Without further information (surgery report, x-ray figures etc.) is this only speculative.Furthermore it must be mentioned that the area of the axis breakage is unknown.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
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