inforMED

DEPUY TOTAL KNEE REPLACEMENT

Received Aug 26, 2013

Report MW5031659 · MDR key 3318750

Device

Generic name

Femoral Cruciate Retaining Cemented

Lot number

310371-3

Product problems

  • Break
  • Defective Device

Patient

51 YR

  • Pain
  • Swelling
  • Ambulation or Postural Difficulties

Narrative

Description of Event or Problem

"FIRST TOTAL KNEE REPLACEMENT ON (B)(6) 2010, ENDURED NEGATIVE SYMPTOMS, CONSTANT LEG SWELLING, LIMPING, AND PAIN. WAS TOLD IT TAKES A YEAR TO HEAL AND WENT BACK TO THE DOCTOR BECAUSE NO IMPROVEMENT IN (B)(6) 2012 (B)(6), GUESSED THAT MEDICAL DEVICE (KNEE COMPONENT) WAS BROKE. ANOTHER SURGERY ON SAME KNEE DONE (B)(6) 2012 AND I REQUESTED POSSESSION OF THE MEDICAL DEVICE AND WAS SHOCKED TO SEE..." IN (B)(6) 2012 I FILED GRIEVANCE WITH HMO (B)(6), MEDICAL RECORD #(B)(4). IN (B)(6) 2012, I FILED A COMPLAINT WITH THE (B)(6) STATE MEDICAL BOARD, CASE # (B)(4). IN (B)(6) 2012, I FILED COMPLAINT WITH DEPUY, JOHNSON & JOHNSONS AND FORWARDED THE COMPONENT TO THEM. NEITHER ACKNOWLEDGE ANY FAULT, COMPENSATED ME, NOR WAIVED HOSPITAL CO-PAY. HAD TO HAVE A SECOND TOTAL KNEE REPLACEMENT ON THE SAME KNEE (LEFT) DUE TO BROKEN MEDICAL DEVICE WITHIN 2.5 YEARS. I FEEL THAT NO ONE HAS ACTED UPON CONCERN FOR THE MEDICAL DEVICE THAT BROKE INSIDE OF MY KNEE, KNEE REPLACEMENT SUPPOSED TO HAVE LONGEVITY OF 12-15 YEARS. I SUFFERED A GREAT DEAL AND MET OTHER PTS AT (B)(4) WITH SAME ISSUES.