inforMED
InjuryLOD

IMPLANT CEMENT BONE PALACOS (R) 1X40

Received Oct 31, 2019 · Event occurred Apr 26, 2017

Report MW5090832 · MDR key 9266368

Device

Generic name

Bone Cement

Manufacturer

Zimmer, Inc.

Lot number

85214571

Product problems

  • Loose or Intermittent Connection
  • Therapeutic or Diagnostic Output Failure
  • Appropriate Device Problem Term/Code Not Available

Patient

63 YR

  • No Information
  • No Information

Narrative

Description of Event or Problem

REQUIRES REVISION SURGERY ON KNEE WITH FAILED IMPLANT DUE TO ASCEPTIC LOOSENING. KNEE IMPLANT WAS PERFORMED USING PALACOS BONE CEMENT. ASCEPTIC LOOSENING CAUSED FAILURE OF KNEE IMPLANT WHICH NOW REQUIRES REVISION. DATE OF SURGERY: (B)(6) 2017. DID THE PROBLEM STOP AFTER USE STOPPED? NO; DID THE PRODUCT RETURN IF STARTING TAKING OR USING THE PRODUCT AGAIN? NO. DO YOU HAVE A PICTURE OF THE PRODUCT? NO, I DID HAVE AN MRI (B)(6). COMPANY NAME: MCKESSON.