ZIMMER NATURAL-KNEE II SYSTEM STEMMED TIBIAL BASEPLATE SIZE 4, LEFT, POROUS COAT
Received Nov 1, 2012 · Event occurred Nov 3, 2010
Report MW5027460 · MDR key 2821136
Device
Generic name
Artificial Knee Component
Manufacturer
Zimmer, Inc.Catalog number
6212-00-240
Lot number
61428572
Product problems
- Loose or Intermittent Connection
Patient
51 YR
- Pain
- Injury
Narrative
Description of Event or Problem
PATIENT PREVIOUSLY HAD LEFT PARTIAL KNEE REPLACEMENT, WHICH HAD PROVEN INSUFFICIENT TO CORRECT JOINT PROBLEMS. PATIENT HAD LEFT TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2010 USING ZIMMER NATURAL KNEE SYSTEM PRODUCTS. SEVERE CHRONIC PAIN AND MOBILITY ISSUES PERSISTED. THE TIBIAL COMPONENT OF THE TKR PROVED FAULTY, FAILED, AND NECESSITATED A REVISION SURGERY WITHIN SIX MONTHS. BEGINNING ON (B)(6) 2011 (12 WEEKS AFTER SURGERY) X-RAYS BEGAN TO SHOW LOOSENING OF THE TIBIAL COMPONENT, WHICH CONTINUED TO WORSEN UNTIL A REVISION OF THE TKR WAS NECESSARY. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2011.