Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Review of part numbers involved in the event found the capitate stem initially implanted is from an older system.This stem is incompatible with the carpal plate and carpal head, which are from a newer design of the system.There are warnings in the package insert that state that this type of event can occur: under warnings, number 1 states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." this report is number 2 of 3 mdrs filed for the same patient (reference 1825034-2016-01683 / 01685).
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During a procedure, the surgeon was unable to assemble the capitate stem, carpal plate, and carpal head.The capitate stem and carpal plate were implanted without the carpal head.There was a thirty minute delay in procedure.The patient subsequently underwent a procedure five days later to remove and replace the plate and stem and implant a head.
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