inforMED
InjuryMAY

RINGLOCK ACETABULAR LINER

Received May 1, 2017 · Event occurred Mar 17, 2016

Report MW5069518 · MDR key 6540799

Device

Generic name

Ringlock Acetabular Liner

Manufacturer

Biomet Orthopedics

Lot number

574900

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.