NEXGEN 16MM DIAMETER 100MM LENGTH STRAIGHT STEM EXTENSION
Received Jul 16, 2026
Report 0002648920-2026-00131 · MDR key 25842247
Device
Generic name
Prosthesis, Knee
Manufacturer
Zimmer Manufacturing B.v.Catalog number
00598801016
Lot number
67638151
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4) D10: 00585004301 - DISTAL FEMORAL XT COMPONENT SIZE C LEFT USE WITH POLYETHYLENE INSERT XT SIZE C USE WITH XT ONLY FOR CEMENTED USE - (B)(6), 00585001396 - POLYETHYLENE INSERT XT SIZE C USE WITH DISTAL FEMORAL XT SIZE C USE WITH XT ONLY (B)(6), 00585003014 - ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE C 14 MM HEIGHT - (B)(6), 00588000500 - SIZE 5 PRECOAT CEMENTED TIBIAL COMPONENT - (B)(6), 00585205014 - FLUTED STEM EXTENSION STRAIGHT PRECOAT FOR CEMENTED USE ONLY 14 MM DIAMETER 130 MM LENGTH - (B)(6), 00585204030 - STEM COLLAR 30 MM O.D. FOR USE WITH 16 MM OR SMALLER DIAMETER SEGMENTAL STEMS (B)(6), 00585004603 - SEGMENT WITH MALE/FEMALE TAPER 30 MM LENGTH -(B)(6), 00585004604 - SEGMENT WITH MALE/FEMALE TAPER 40 MM LENGTH - (B)(6), 00801102032 - ALLEN MEDULLARY CEMENT PLUGS 1-32 MM DIAMETER FLANGE/16MM DIAMETER CORE STORE IN COOL DRY PLACE - (B)(6), 00801102032 - ALLEN MEDULLARY CEMENT PLUGS 1-32 MM DIAMETER FLANGE/16MM DIAMETER CORE STORE IN COOL DRY PLACE - (B)(6), 00223200418 - CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH -(B)(6). G2 : FOREIGN COUNTRY : AUSTRALIA H6: MECHANICAL (G04) - STEM 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 THE PATIENT UNDERWENT A KNEE SURGERY AND SUBSEQUENTLY PASSED AWAY ON AN UNKNOWN DATE FOLLOWING THE SURGERY DUE TO MEDICAL COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.