inforMED
MalfunctionHSH

STRYKER ORTHOPEDICS

Received Jun 27, 2013 · Event occurred Jun 24, 2013

Report MW5030726 · MDR key 3204003

Device

Generic name

Tibial Bearing Insert 11mm

Model number

5530P811

Lot number

1CH091

Product problems

  • Device Operates Differently Than Expected

Patient

66 YR

  • Pain
  • Scar Tissue
  • Swelling
  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

PATIENT HAD A LEFT KNEE HARDWARE REMOVAL SECONDARY TO PAIN, SWELLING, LOCKING, CATCHING AND POPPING OF THE KNEE. REMOVAL OF THE HARDWARE WAS NECESSARY TO "PREVENT PERMANENT IMPAIRMENT OF THE BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE." OPERATIVE REPORT STATES LEFT KNEE REVISION TOTAL KNEE REPLACEMENT WITH EXCISION OF A LARGE CEMENT FRAGMENT. SIGNIFICANT SCAR TISSUE WAS REMOVED. POLYETHYLENE WAS REMOVED ALSO. THE 13MM X 8MM CR POLY WAS INSERTED TO REPLACE THE EXPLANTED 11MM POLY. REPLACEMENT WAS A STRYKER ORTHO TIBIAL BEARING INSERT. EXPLANT WAS SENT PER REQUEST OF SURGEON TO (B)(6) ORTHOPEDIC LAB.