inforMED
InjuryJWH

SIGMA RP TC3 INSERT SIZE 3 MM 17.5

Received Jun 8, 2011 · Event occurred May 18, 2011

Report 2122630 · MDR key 2122630

Device

Generic name

Tibial Insert

Manufacturer

Depuy

Model number

96-2344

Catalog number

*

Lot number

ZN3DA4000

Product problems

  • Device Slipped

Patient

77 YR

  • Unspecified Infection
  • No Code Available

Narrative

Description of Event or Problem

PT HAD ORIGINAL TOTAL KNEE REPLACEMENT IN 2003. PATIENT HAD A SUBSEQUENT TOTAL KNEE REVISION SEVERAL YEARS LATER. PATIENT RETURNED TO THE OR RECENTLY DUE TO LOOSENING OF PROSTHESIS. PHYSICIAN FELT THAT IMPLANTS LOOSENED QUICKLY AFTER HIS LAST REVISION SURGERY. COMPONENTS REMOVED AND ANTIBIOTIC SPACER IMPLANTED DUE TO SUSPECTED INFECTION (NEGATIVE CULTURES).