NEXGEN 15MM DIAMETER 100MM LENGTH STRAIGHT STEM EXTENSION COMBINED LENGTH 145MM
Received Jul 9, 2026 · Event occurred Apr 13, 2026
Report 0002648920-2026-00129 · MDR key 25765941
Device
Generic name
Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Manufacturer
Zimmer Manufacturing B.v.Catalog number
00598801015
Lot number
65467122
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
80 YR · Male
- Pain
- Metal Related Pathology
- Aseptic loosening
- Periprosthetic fracture
Narrative
Additional Manufacturer Narrative
(B)(4) D10: 00599401691 - LCCK FEM IMPLANT SZ F-L - 65617996. G2: FOREIGN - EVENT OCCURRED IN CZECH REPUBLIC. 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 REVISION SURGERY APPROXIMATELY 2.5 YEARS POST IMPLANTATION DUE TO PAIN AND FEMORAL FRACTURE. X-RAY EVALUATION REVEALED A FEMORAL FRACTURE AT THE POINT OF CONNECTION WITH THE STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.