inforMED

SIGMA

Received Jun 22, 2013 · Event occurred Oct 4, 2010

Report MW5030682 · MDR key 3193604

Device

Generic name

Cr 150

Manufacturer

Depuy

Product problems

  • Device Operates Differently Than Expected
  • Noise, Audible

Patient

58 YR

  • Inflammation
  • Pain
  • Loss of Range of Motion
  • Swelling

Narrative

Description of Event or Problem

TOTAL KNEE REPLACEMENT DEPUY SIGMA CR 150 DONE BY (B)(6). AFTER TWO MONTHS OF PT 3/WK FLEXION WAS UNDER 90 DEGREES. HAD NON SURGICAL MANIPULATION IN (B)(6) IN (B)(6) WITH SAME SURGEON. PT FOLLOWED UNTIL (B)(6) 2011 WITH NO IMPROVEMENT OF FLEX. RETURN TO SURGEON IN (B)(6) 2011 TO UNDERGO ARTHROSCOPIC MANIPULATION OF KNEE. PT FOLLOWED FOR TWO MONTHS WITH LITTLE OR NO IMPROVEMENT. KNEE FUNCTION OK THROUGH 2012 WITH THE LIMITED FLEX BUT SMALL AMOUNT OF PAIN AND SWELLING. (B)(6) 2013, LOST 20 DEGREES OF FLEXION DOWN TO 68-70 DEGREES. INCREASED PAIN AND CONSTANT INFLAMMATION WITH LITTLE EXERTION. STOPPED MY 2 MILE WALK/DAY. CREPITUS NOTICED BILATERALLY BY (B)(6) HERE IN (B)(6). ALL ADVERSE CONDITIONS CONTINUE TO PRESENT. DR (B)(6) RETIRED ABOUT 15 MONTHS AFTER MY OPERATION. (B)(6) MERGED WITH PROLINE A LARGER BUSINESS WITH ABOUT 40 CLINICS IN (B)(6). SUBGROUP IS CALLED (B)(6). FORMER NAME IS NO LONGER BEING USED APPARENTLY. DR (B)(6) TOLD ME VIA PHONE THAT NO ONE IS FOLLOWING UP DIRECTLY WITH HIS PTS, BUT A DR (B)(6) HAS A SIMILAR BACKGROUND AND HAS FORMER PT'S FILES. (B)(6) 2010, (B)(6) 2011.