inforMED
InjuryJWH

KNEE REPLACEMENT IMPLANT

Received Aug 20, 2024 · Event occurred Jun 16, 2024

Report MW5158637 · MDR key 20013341

Device

Generic name

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal

Manufacturer

Exactech Sarasota

Patient

63 YR · Female

  • Failure of Implant
  • Failure of Implant

Narrative

Description of Event or Problem

CALLER STATED THAT SHE WAS IMPLANTED WITH THREE KNEE REPLACEMENT DEVICE BY THREE MANUFACTURERS AND ALL THREE DEVICES FAILED. SO FAR SHE HAD TWO REVISIONS AND AWAITING A THIRD ONE. THE FIRST IMPLANT WAS AN EXACTECH LEFT KNEE IMPLANTED ON (B)(6) 2009 AND WAS REVISED ON (B)(6) 2023 BECAUSE THE DEVICE WAS RECALLED. REPORTER STATED THAT THERE ARE SIXTEEN (16) PIECES OF HARDWARE IMPLANTED IN THE LEFT KNEE BESIDES THE KNEE REPLACEMENT DEVICE. REF REPORTS: MW5158638, MW5158639.