PROFEMUR® MODULAR FEMORAL NECK

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

Description of Event or Problem

ALLEGEDLY, THE PATIENT COMMENTED THAT THE DISLOCATION OCCURRED WHEN HE TWISTED HIS BODY FROM A LONG SITTING POSITION AT HOME. THE G26-47MM/26MM+0 HEAD/VV8 NECK WAS REMOVED, AND AFTER ANOTHER TRIAL, THE SAME SIZE WAS SELECTED AND THE INSTALLATION OPERATION WAS COMPLETED. NO TRIAL WAS PERFORMED AT THE LAST REVISION ON (B)(6) 2023. THE AFFINITY BETWEEN THE ACETABULUM AND THE CUP WAS SO HIGH THAT A 26MM HEAD & POLYETHYLENE ONLY MONOPOLAR CONDITION MAY HAVE OCCURRED. SO, WE ASKED HIM TO DO A TRIAL THIS TIME AND CONFIRMED THAT IT WAS IN BIPOLAR CONDITION. PHYSICIAN'S FINDINGS: THERE HAS BEEN AN ONGOING G26 DISLOCATION AT OUR FACILITY, AND WE HAVE DOUBTS ABOUT THE DISLOCATION RESISTANCE STRENGTH OF THE RELEVANT IMPLANT. WE HAVE CONFIRMED THAT THERE WAS NO SOFT TISSUE ENTRAPMENT AT THE TIME OF THE PREVIOUS REVISION, AND WOULD LIKE YOU TO RECONFIRM THE CAUSE OF THE CURRENT DISLOCATION. WE ALSO HOPE THAT THE MANUFACTURER WILL SHARE THE STATUS OF SIMILAR DEFECT REPORTS (CASES OF DISLOCATION FOR THE ENTIRE G26 / CASES OF DISLOCATION BY APPROACH). FINDINGS OF THE REPORTER AND STATUS OF RESPONSE: THERE WAS NO EVIDENCE OF DAMAGE TO THE REMOVED IMPLANT. HOWEVER, THERE WAS A BLACK DISCOLORATION AT THE NECK AREA, AND THERE WAS A POSSIBILITY OF NECK CUP IMPINGEMENT. DURING THE PRE-OPERATIVE AND POST-OPERATIVE DISCUSSIONS WITH THE DOCTOR, THE PATIENT'S FAMILY COMMENTED THAT, DUE TO THE PATIENT'S BACKGROUND (DEMENTIA/PSYCHIATRIC DISORDER), THEY FELT THAT IN ADDITION TO DISLOCATION DUE TO THE PATIENT'S CLAIMED LIMB POSITION, OTHER FACTORS SUCH AS A FALL MIGHT ALSO HAVE CONTRIBUTED TO THE DISLOCATION. HOWEVER, THE DOCTOR FELT THAT THE PATIENT'S DISLOCATION HAD CONTINUED. HOWEVER, THE DOCTOR FELT THAT THE FACT OF CONTINUED DISLOCATION IS A FACT, AND HE WOULD LIKE TO KNOW THE MANUFACTURER'S OPINION ON THE CURRENT SITUATION SO THAT HE CAN CONTINUE TO USE THE PRODUCT WITH PEACE OF MIND. (B)(6).