Endo-Model Modular Knee Prosthesis System 15-2964/03Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · Femoral Segment · Class 2 · Implant
All models of Endo-Model Modular Knee Prosthesis System (64)
Data updated Oct 18, 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 04026575205882), received between Jul 18, 2024 and Jul 24, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant1
- Implant Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2024Fracture; Fracture
PATIENT HAS A HISTORY OF FIBROSIS ASSOCIATED WITH NICKEL ALLERGY AND PAIN IN HIS RIGHT KNEE. ON (B)(6) 2023 THE PATIENT UNDERWENT REVISION SURGERY DURING WHICH THIS POREX-COATED KNEE SYSTEM WAS IMPLANTED WITH UHMWPE DISTAL FEMORAL AND PROXIMAL TIBIAL AUGMENTS. IMAGING REVEALS FRACTURED DISTAL FEMUR CEMENT MANTLE EXPOSING THE AUGMENTS. REVISION SURGERY IS PLANNED PENDING AVAILABILITY OF PARTS TO BE PROVIDED UNDER COMPASSIONATE USE. [CUSTOMER].
Patient problems: Failure of Implant
MAUDE report 19815727 ↗InjuryJul 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PATIENT HAS A HISTORY OF FIBROSIS ASSOCIATED WITH NICKEL ALLERGY AND PAIN IN HIS RIGHT KNEE. ON (B)(6) 2023 THE PATIENT UNDERWENT REVISION SURGERY DURING WHICH THIS POREX-COATED KNEE SYSTEM WAS IMPLANTED WITH UHMWPE DISTAL FEMORAL AND PROXIMAL TIBIAL AUGMENTS. IMAGING REVEALS FRACTURED DISTAL FEMUR CEMENT MANTLE EXPOSING THE AUGMENTS. REVISION SURGERY IS PLANNED PENDING AVAILABILITY OF PARTS TO BE PROVIDED UNDER COMPASSIONATE USE ((B)(4)).
Patient problems: Implant Pain
MAUDE report 19777452 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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