SMARTSET MV
Received Nov 26, 2013 · Event occurred Jan 1, 2009
Report MW5033123 · MDR key 3493715
Device
Product problems
- Device Slipped
Patient
49 YR
- Erythema
- Pain
- Swelling
- Discomfort
- Disability
Narrative
Description of Event or Problem
THE REPORTER HAD A KNEE REPLACEMENT IN 2009. RIGHT AFTER THE IMPLANT, SHE STARTED TO EXPERIENCE PAIN. SHE WENT BACK TO (B)(6) WHERE SHE GOT THE IMPLANT, AND WAS TOLD TO GIVE IT TIME FOR HER KNEE TO HEAL. SHE CONTINUES TO EXPERIENCE PAIN, SWOLLEN KNEES, AND REDNESS AT THE IMPLANT SITE, SHE WENT BACK TO (B)(6) BUT DID NOT GET ANY HELP. SHE LATER GOT IN TOUCH WITH ANOTHER DOCTOR THROUGH (B)(6) WHO DECLARED THE DEVICE AS LOOSE AND SHE SHOULD EITHER HAVE IT CORRECTED OR EXPLANTED. SHE STOPPED WORKING BECAUSE OF PAIN AND DISCOMFORT. SHE TAKES A LOT OF PAIN MEDICATION BUT NOTHING HELPS. SHE FELL A COUPLE OF TIMES BECAUSE THE IMPLANT IS UNSTABLE BECAUSE IT WOBBLES. COMPONENT IMPLANTED DEPUY PFC SIGMA NON-PORUS CRUCIATE SUBSTITUTING FEMORAL. COMPONENT SIZE 1.5 WHITE CEMENT TIBIAL BASE PLATE COBALT CHROME SIZE 2. POSTERIOR STABILIZED POLYETHYLENE TIBIAL INSERT SIZE 2 BY 8MM 3 PEG ROUND DOME PATELLA 32 MM.