InjuryKWL
ENDO-MODEL SADDLE PROSTHESIS
Received Jul 9, 2026 · Event occurred Jun 11, 2026
Report 3004371426-2026-00056 · MDR key 25758418
Device
Generic name
Endo-model Sled Prosthesis, Saddle Segment, With Suture Hole, Uhmwpe, Cocrmo,
Manufacturer
Waldemar Link Gmbh & Co. KgModel number
99-8007/13Catalog number
99-8007/13
Product problems
- Unintended Movement
Patient
36 YR · Female
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE PRODUCTION RECORDS HAVE BEEN INSPECTED AND REVIEWED. ADDITIONAL STEPS HAVE BEEN TAKEN TO RELEASE THE PRODUCT.
Description of Event or Problem
"NOTIFED BY (B)(6) THAT A SADDLE PROTHESIS IMPLANTED IN 2019 BY DR. (B)(6), WILL REQUIRE A REVISION USING A COMPASSIONATE USE PART, WITH DR. (B)(6). DR. (B)(6) PROVIDED SOME INFORMATION ON (B)(6) 2026 AS TO WHETHER HE BELIEVED THE DEVICE CAUSED THE NEED FOR A REVISION. HE BELIEVES THE PART IS DISASSOCIATED." [CUSTOMER].