InjuryKWL
ENDO-MODEL SADDLE PROSTHESIS
Received Jul 6, 2026
Report 3006721341-2026-00014 · MDR key 25725437
Device
Generic name
Endo-model Saddle Prosthesis
Manufacturer
Waldemar Link Gmbh & Co. KgModel number
99-8007/13Catalog number
99-8007/13
Lot number
130820
Product problems
- Detachment of Device or Device Component
Patient
36 YR · Female
- Joint Laxity
Narrative
Description of Event or Problem
NOTIFIED BY (B)(6). THAT A SADDLE PROTHESIS IMPLANTED IN 2019 BY DR (B)(6). WILL REQUIRE A REVISION USING A COMPASSIONATE USE PART (2026-0241), WITH DR. (B)(6). DR. (B)(6) BELIEVES THE PART IS DISASSOCIATED.