28MM +12 V40 TAPER VIT HEAD

Additional Manufacturer Narrative

REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED: PT. REPORTED; SHE HAD HER INITIAL HIP REPLACEMENT ON (B)(6) 2010. SHE EXPERIENCED A LOT OF PAIN AND IT STARTED TO DISLOCATE AFTER 11 YEARS. ON (B)(6) 2021, SHE HAD HER 1ST REVISION FOR DISLOCATION. A SECOND HIP REPLACEMENT WHICH WAS ALSO A STRYKER PRODUCT WAS IMPLANTED. SHE HAD COMPLAINTS ABOUT IT FROM THE MOMENT IT WAS PUT IN. IT JUST WASN'T COMFORTABLE IT DIDN'T FEEL RIGHT. THERE WAS A LOT OF PAIN FOR THREE YEARS AND SHE WAS TOLD EVERYTHING WAS FINE THERE WAS NOTHING WRONG WITH THE PRODUCT. IN (B)(6) 2025 SHE WENT FOR A SECOND OPINION AND IT WAS DISCOVERED THAT THE BALL WAS WEARING ON THE STEM CAUSING A RIDGE TO DEVELOP, THE SCREW WHICH HELD THE BALL WAS BROKEN, SHE HAD SEVERE BONE LOSS, AND METAL SHAVINGS BASICALLY FALLEN OFF INTO HER BODY. THE SECOND REVISION WHICH WAS AN EMERGENCY HIP REPLACEMENT WAS PERFORMED ((B)(6) 2025) WITH NON-STRYKER IMPLANTS. IT WAS DISCOVERED SHE HAD SEVERE BONE LOSS. PER THE ORTHOPEDIC SURGEON; IT LOOKED LIKE A BOMB HAD GONE OFF ON HER LEG AND THE SURGERY WAS INTENSE. THIS HAS LEFT HER RELYING ON SOME SORT OF WALKING ASSISTANCE DEVICE. PT. FURTHER STATED HER QUALITY OF LIFE HAS COMPLETELY CHANGED; SHE'S BEEN IN PAIN AND SUFFERING FOR THE LAST FIVE YEARS. 2ND REVISION.