NA 00-5850-042-02Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024195936), received between Feb 24, 2020 and Sep 24, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Aseptic loosening1
- Damage to Ligament(s)1
- Fall1
- Insufficient Information1
- No Information1
- Osteolysis1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50889529 ↗InjuryNov 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 23478631 ↗InjuryJul 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THE PATIENT UNDERWENT A KNEE PROCEDURE. APPROXIMATELY 4 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO FEMORAL LOOSENING. THE FEMORAL COMPONENT AND POLY WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening
MAUDE report 22396195 ↗InjuryJul 22, 2020Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY 11 MONTHS POST IMPLANTATION DUE TO FRACTURE OF THE FEMORAL COMPONENT. SUBSEQUENTLY, THE PATIENT UNDERWENT AN ADDITIONAL REVISION APPROXIMATELY 12 MONTHS LATER DUE TO A FALL AND FRACTURE OF THE FEMORAL COMPONENT.
Patient problems: Fall
MAUDE report 10308460 ↗InjuryFeb 24, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IS SCHEDULED FOR A REVISION DUE TO IMPLANT FRACTURE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.
Patient problems: Damage to Ligament(s); No Information
MAUDE report 9746036 ↗
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 1115-1213United 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 1115-1217United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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