8MM PT2 ALLPOLY TIB KRH XXSML

Additional Manufacturer Narrative

IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT AFTER TRIALING, COMPONENTS WERE CEMENTED IN WHEN IT WAS DISCOVERED THAT THE IMPLANTS WERE MUCH LONGER THAN THE TRIALS (TRIALS AND IMPLANTS WERE MATCHED). A SURGICAL DELAY OF 1 HOUR WAS CAUSED BY THE NEED TO EXPLANT ALL DEVICES AND RE-IMPLANT DEVICES WHICH FIT THE PATIENT. NO TOURNIQUET WAS USED.

Additional Manufacturer Narrative

AN EVENT REGARDING SIZE/FIT ISSUE INVOLVING A KRH TIBIAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: IT WAS REPORTED THAT DURING PATIENTS RIGHT KNEE SURGERY, AFTER TRIALING, COMPONENTS WERE CEMENTED IN WHEN IT WAS DISCOVERED THAT THE IMPLANTS WERE MUCH LONGER THAN THE TRIALS (TRIALS AND IMPLANTS WERE MATCHED). A SURGICAL DELAY OF 1 HOUR WAS NOTED. VISUAL INSPECTION OF THE RECEIVED IMAGE OF THE DEVICE NOTED THAT THE DEVICE WAS COVERED WITH STAINS OF BLOOD. THE EVENT WAS NOT CONFIRMED NEITHER THE ROOT CAUSE COULD BE DETERMINED SINCE INSUFFICIENT INFORMATION WAS AVAILABLE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

Description of Event or Problem

PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT AFTER TRAILING, COMPONENTS WERE CEMENTED IN WHEN IT WAS DISCOVERED THAT THE IMPLANTS WERE MUCH LONGER THAN THE TRIALS (TRIALS AND IMPLANTS WERE MATCHED). A SURGICAL DELAY OF 1 HOUR WAS CAUSED BY THE NEED TO EXPLANT ALL DEVICES AND RE-IMPLANT DEVICES WHICH FIT THE PATIENT. NO TOURNIQUET WAS USED.