PERSONA ALL-POLY PATELLA CEMENTED 35 MM DIAMETER
Received Jul 22, 2026 · Event occurred Jun 23, 2026
Report 0002648920-2026-00132 · MDR key 25906320
Device
Generic name
Prosthesis, Knee
Manufacturer
Zimmer Manufacturing B.v.Model number
N/ACatalog number
42540200035
Lot number
66134496
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Pain
Narrative
Additional Manufacturer Narrative
(B)(4). D10: 42-5020-064-02, RIGHT CR FEMUR 8 NARROW, 65962899. 42-5320-071-02, RIGHT E TIBIA, 66099110. 42-5220-005-10, RIGHT 10MM CR ART SURFACE 3-11, 65849780. G2: FOREIGN: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TKA. SUBSEQUENTLY, A REVISION WAS PERFORMED DUE TO PAIN ABOUT 2.5 YEARS POSTOP. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.