ENDO-MODELL MODULAR
Received Apr 10, 2024 · Event occurred Mar 19, 2024
Report 3004371426-2024-00030 · MDR key 19077844
Device
Generic name
Endo-m. Mod.rotationknee, Fem. Comp.,w. Patellar Flange,medium, Right
Manufacturer
Waldemar Link Gmbh & Co. KgModel number
15-2812/11Catalog number
15-2812/11
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
77 YR · Male
- Failure of Implant
- Pain
- Failure of Implant
- Pain
Narrative
Description of Event or Problem
FEMUR HAT SICH VOM SCHAFT GELÖST. PATIENT IST ANSCHEINEND SO SCHON SEIT LÄNGER ZEIT RUM GELAUFEN. SCHAFT WAR FEST IM. ZEMENTMANTEL. [CUSTOMER]. TRANSLATION: FEMUR HAS DETACHED FROM THE STEM.
Additional Manufacturer Narrative
THE PRODUCTION RECORDS OF REF: (B)(4) CANNOT BE VIEWED AND CHECKED DUE TO THE MISSING SERIAL NUMBER. THIS IS THE FINAL SUPPLEMENTAL REPORT. THE COMPLAINT IS CLOSED.
Description of Event or Problem
FEMUR HAT SICH VOM SCHAFT GELÖST. PATIENT IST ANSCHEINEND SO SCHON SEIT LÄNGER ZEIT RUM GELAUFEN. SCHAFT WAR FEST IM ZEMENTMANTEL. [CUSTOMER]. TRANSLATION: FEMUR HAS DETACHED FROM THE STEM.