COLLECT.NO.QAS KNEE IMPLANTS VEGA

Additional Manufacturer Narrative

EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.

Description of Event or Problem

COUNTRY OF COMPLAINT: USA. ABOUT A YEAR AGO, A SURGEON IMPLANTED A VEGA TOTAL KNEE AT (B)(6). UPON FOLLOW UP, THE VEGA TIBIAL COMPONENT HAS LOOSENED. THEY BECAME AWARE THAT THIS OCCASIONALLY HAPPENS; HOWEVER, THE SURGEON NOW HAS CONFIRMED THAT THIS IN NOT AN ISOLATED INCIDENT. HE NOW HAS TWO PATIENTS THAT HAVE CONFIRMED LOOSE TIBIA BASEPLATES (AND THEY ARE IN NEED OF REVISION). ADDITIONALLY, HE IS "KEEPING A CLOSE EYE ON" TWO MORE PATIENTS THAT HE SUSPECTS HAVE LOOSE TIBIAS. THIS IS A TOTAL OF 4 PATIENTS. ALL PATIENTS REPORTED ARE LESS THAN A YEAR POST OP. THE SURGEON SUSPECTS THAT THIS ISSUE MAY HAVE COME FROM SURGICAL TECHNIQUE. INITIALLY, HE IMPLANTED THE TIBIAL, FEMORAL, AND MENISCAL COMPONENTS INTO THE PATIENT AND LOCKED THE POLY SCREW INTO PLACE BEFORE THE CEMENT HAD A CHANCE TO HARDEN. APPARENTLY, THE SURGEON WAS INFORMED THAT THIS A IMPROPER TECHNIQUE - HE SHOULD WAIT UNTIL THE CEMENT HAS HARDENED BEFORE THE POLY SCREW IS IMPLANTED. HE HAS SINCE CHANGED HIS SURGICAL TECHNIQUE. IF THIS IS THE REASON WHY THERE ARE LOOSE TIBIA BASEPLATES IN HIS PATIENTS, THEN THE PROBLEM IS SOLVED (HOPEFULLY WE DON'T SEE ANY MORE LOOSENING). NO INJURY TO PATIENT. NO DELAY IN SURGERY. NO ADDITIONAL INTERVENTION REQUIRED. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2018-00005, 9610612-2018-00006.

Additional Manufacturer Narrative

INVESTIGATION: NO PRODUCT IS AT HAND. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE LOT NUMBER AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: NO PRODUCT AVAILABLE AND THEREFORE AN ANALYSIS IS NOT POSSIBLE BUT WE ASSUME BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE FAILURE IS NOT PRODUCT RELATED. RATIONAL: IT COULD BE POSSIBLE THAT THERE WERE PROBLEMS WITH THE CEMENT TECHNIQUE. NO CAPA IS NECESSARY.