Endo-Model Saddle Prosthesis 99-8007/13Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · Saddle Component,with suture holes · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575401482), received between Jul 6, 2026 and Jul 9, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Unintended Movement1
Patient problems
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2026Unintended Movement
"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].
Patient problems: Insufficient Information
MAUDE report 25758418 ↗InjuryJul 6, 2026Detachment of Device or Device Component
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.
Patient problems: Joint Laxity
MAUDE report 25725437 ↗
Other Prosthesis, Hip, Hemi-, Femoral, Metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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