UNKN JOURNEY II BCS KNEE INSERT

Additional Manufacturer Narrative

THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL / MEDICAL INVESTIGATION CONCLUDED THAT PER COMPLAINT DETAILS, THE PATIENT STEPPED OFF A GAME DRIVING TRUCK AND THE TIP OF THE BCS PEG BROKE OFF AND WAS ¿LYING IN THE JOINT SPACE¿ AND ¿CAUSED METALLOSIS¿. REPORTEDLY, A POLY REVISION WAS PERFORMED. THE PROVIDED UNDATED/UNIDENTIFIED IMAGING DOES NOT PROVIDE INSIGHT INTO THE ROOT CAUSE OF THE REPORTED EVENT AND DOES NOT VISUALLY SUPPORT METALLOSIS IN/AROUND THE LEFT JOINT SPACE BUT THE FEMORAL COMPONENT DOES APPEAR TO SIT SLIGHTLY ANTERIOR THAN WOULD BE EXPECTED TO CONFIRM A BROKEN BCS PEG. NO DELAY OR ADDITIONAL INTERVENTIONS OR ADDITIONAL COMPLICATIONS WERE REPORTED. IT WAS COMMUNICATED THAT NO FURTHER CLINICALLY RELEVANT DOCUMENTATION WOULD BE PROVIDED FOR INCLUSION IN THE MEDICAL INVESTIGATION. THE ROOT CAUSE OF THE REPORTED EVENT WAS REPORTEDLY THE PATIENT STEPPING OFF A GAMING TRUCK; HOWEVER, THIS COULD NOT BE DEFINITIVELY CONCLUDED. THE X-RAY IMAGES DO NOT SUPPORT THE REPORTED METALLOSIS AND COULD NOT BE CONFIRMED WITHOUT THE REQUESTED MEDICAL DOCUMENTATION. THE REPORTED PATIENT IMPACT WAS THE ¿METALLOSIS¿ AND POLY-INSERT REVISION. FURTHER PATIENT IMPACT COULD NOT BE ASSESSED. NO FURTHER MEDICAL ASSESSMENT COULD BE RENDERED AT THIS TIME. SHOULD ADDITIONAL CLINICAL DOCUMENTATION BECOME AVAILABLE IN THE FUTURE, THE CLINICAL/MEDICAL TASK MAY BE RE-EVALUATED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. SOME POTENTIAL PROBABLE CAUSES FOR THIS EVENT COULD INCLUDE BUT NOT LIMITED TO TRAUMATIC INJURY, SURGICAL TECHNIQUE, IMPLANT FAILURE, DAMAGED PRODUCT, IMPLANT CORROSION OR WEAR. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON 2014, THE PATIENT STEPPED OFF A GAME DRIVING TRUCK CAUSING THE JOURNEY II BCS KNEE INSERT TO BREAK, LAY IN THE JOINT SPACE AND METALLOSIS. THE ISSUE WAS ADDRESSED VIA REVISION SURGERY FOR REPLACEMENT OF THE IMPLANT. THE PATIENT OUTCOME IS UNKNOWN.