No product is returned for review.This complaint does not allege that the devices failed to meet specification.Insufficient information has been provided to perform a device history records review.However, a complaint of this nature would not benefit from a review of manufacturing documentation.These devices were used for the treatment of a disease.No specific patient history is available.A complaint search of the manufacturing lot cannot be performed without receipt of the device lot number.This combination of products is considered an off-label use of the device as stated in the ifu.Zimmer has not tested the compatibility of this combination of devices.The ifu states, "only authorized combinations should be used.To determine whether these devices have been authorized for use in a proposed combination, please contact your zimmer sales representative or visit the zimmer website: www.Productcompatibility.Zimmer.Com." the cause of the described event is a failure to follow instructions.
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