RINGLOCK ACETABULAR LINER
Received May 1, 2017 · Event occurred Mar 17, 2016
Report MW5069518 · MDR key 6540799
Device
Product problems
- Fracture
- Material Fragmentation
Patient
69 YR
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
BILATERAL HIP REPLACEMENTS APPROXIMATELY 1998. LEFT SIDE REVISED (SAME MANUFACTURER - BIOMET) (B)(6) 2015 - WHICH WAS A GOOD LONG TIME. ON (B)(6) 2016 HEARD A LOUD CRACK WHILE WALKING QUIETLY DOWN THE SIDEWALK. NO PAIN, BUT LOUD SQUEAKING NOISE WHEN WALKING. CT SCAN 07/22 CONFIRMED PLASTIC LINER HAD SHATTERED. SECOND REVISION PERFORMED (B)(6) 2016 AT (B)(6) HOSPITAL IN (B)(6). ALL FOUR SURGERIES PERFORMED BY SAME SURGEON AND ALL WITH BIOMET COMPONENTS. PROSTHESIS IS NOT METAL ON METAL, BUT RATHER TITANIUM, CERAMIC, AND POLYETHYLENE PLASTIC. BIOMET REP PRESENT DURING 2016 REVISION SURGERY AND TOOK PLASTIC PIECES FOR EXAMINATION, BUT HAS NEVER RESPONDED TO REQUESTS FOR RESULTS (PER SURGEON). CERAMIC HEAD DAMAGED THE ACETABULAR CUP, SO REPLACEMENT PLASTIC LINER HAD TO BE ALTERED AND CEMENTED IN PLACE INSTEAD OF THE USUAL ATTACHMENT METHOD IN THE LAST REVISION. FINALLY RECEIVED HOSPITAL IMPLANT RECORD FOR 2015 SURGERY AT THE END OF (B)(6) 2016.