Endo-Model Modular Knee Prosthesis System 15-8521/26Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · Rotational Knee Joint Prosthesis,Femoral component, intracondylar · Class 2 · Implant
All models of Endo-Model Modular Knee Prosthesis System (64)
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 04026575386468), received between Jul 23, 2024 and Jul 25, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Expiration Date Error” (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
- Expiration Date Error1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2024Expiration Date Error; Expiration Date Error
IT WAS IDENTIFIED DURING ORDER INVOICE PROCESSING THAT AN EXPIRED DEVICE WAS IMPLANTED IN THE PATIENT. THE DEVICE EXPIRED ON 2024-04, AND WAS IMPLANTED ON (B)(6) 2024. THE REP CONFIRMED THAT THE VACUUM SEAL ON THE IMPLANT WAS INTACT AND THE SURGEON WILL BE NOTIFIED.. [CUSTOMER].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19825956 ↗InjuryJul 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS IDENTIFIED DURING ORDER INVOICE PROCESSING THAT AN EXPIRED DEVICE WAS IMPLANTED IN THE PATIENT. THE DEVICE EXPIRED ON 2024-04, AND WAS IMPLANTED ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19809423 ↗
Other Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer devices
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- ELEOS™ THSMWRS01MOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER190 reports
- "UNITED" USTAR II Hip System 1115-1413United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls3 reports
- "UNITED" USTAR II Hip System 1115-1217United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1417United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1213United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 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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