Endo-Model Standard Knee Prosthesis System 15-2516/29Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04026575204212), received between Sep 10, 2024 and Sep 25, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2025Unstable; Appropriate Device Problem Term/Code Not Available; Unstable; Appropriate Device Problem Term/Code Not Available

  REPORTED TO LINKBIO, ON (B)(6) 2025, THAT THIS PATIENT WILL REQUIRE A REVISION OF THE EXISTING LINK DEVICE WITH A CUSTOM-MADE IMPLANT. DR. BELIEVES THE CURRENT IN-SITU LINK DEVICE CONTRIBUTED TO THE NEED FOR REVISION, AS THE PLASTIC IN THE TIBIAL COMPONENT IS COMPRESSIBLE AND IS CAUSING THE PATIENT PAIN. [CUSTOMER] THE REVISION HAS NOT BEEN PERFORMED YET.

  Patient problems: Pain

  MAUDE report 23140784 ↗
• InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DURING A TELEPHONE VISIT WITH THE PATIENT ON (B)(6) 2025, THE SURGEON RECOMMENDED THE PATIENT UNDERGO REVISION TKA FOR KNEE PAIN. DURING A PRIOR VISIT ON (B)(6) 2025, THE X-RAYS SHOWED WELL-FIXED TIBIAL AND FEMORAL COMPONENTS, BUT THE PHYSICIAN BELIEVES A POLYETHYLENE AUGMENT (IMPLANTED (B)(6) 2022) MAY BE CAUSING PAIN.

  Patient problems: Implant Pain

  MAUDE report 22904776 ↗
• InjuryJan 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IN A REQUEST FORM FROM DR. M FOR A COMPASSION USE REVISION, THE DOCTOR MENTIONED THAT HE SUSPECTED THAT THE POLY AUGMENTS IMPLANTED ON (B)(6) 2021 MAY BE LOOSE. RECEIVED THE POST-OP REPORT ON (B)(6) 2025 , STATING THAT THE TIBIAL COMPONENT SHOWED EVIDENCE OF LOOSENING. THE REVISION WAS COMPLETED ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 21232687 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT KNEE REVISION SURGERY (B)(6) 2021 FOR A PREVIOUSLY INFECTED KNEE (MANUFACTURER UNKNOWN) AND NICKEL ALLERGY. THIS TIBIAL AUGMENT WAS IMPLANTED AT THAT TIME WITH A LINK POREX KNEE SYSTEM. IT APPEARS THAT THE FEMORAL SIDE WAS LATER REVISED (CAUSE UNKNOWN) ON (B)(6) 2023. DR. NOW PLANS TO REVISE THIS PATIENT DUE TO RIGHT KNEE PAIN, WHICH HE SUSPECTS IS RELATED TO THE UHMWPE TIBIAL AUGMENT. [CUSTOMER]

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Unspecified Infection

  MAUDE report 20187871 ↗
• InjurySep 10, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT UNDERWENT KNEE REVISION SURGERY (B)(6) 2021 FOR A PREVIOUSLY INFECTED KNEE (MANUFACTURER UNKNOWN) AND NICKEL ALLERGY. THIS TIBIAL AUGMENT WAS IMPLANTED AT THAT TIME WITH A LINK POREX KNEE SYSTEM. IT APPEARS THAT THE FEMORAL SIDE WAS LATER REVISED (CAUSE UNKNOWN) ON (B)(6) 2023. DR. NOW PLANS TO REVISE THIS PATIENT DUE TO RIGHT KNEE PAIN, WHICH HE SUSPECTS IS RELATED TO THE UHMWPE TIBIAL AUGMENT.

  Patient problems: Implant Pain

  MAUDE report 20181768 ↗