NA 00-5850-020-14Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024195691), received between Jan 10, 2023 and Sep 24, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Unstable” (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
- Adverse Event Without Identified Device or Use Problem2
- Unstable1
- Use of Device Problem1
Patient problems
- Insufficient Information2
- Osteolysis1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient had a TKA on an unknown date. Subsequently, a knee revision was being considered due to chronic infection and loosening. Attempts have been made and no further information has been provided.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50883324 ↗InjuryDec 29, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO INSTABILITY. DURING THE REVISION, IT WAS NOTED THAT THE FEMORAL HAD FRACTURED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18419176 ↗InjuryJan 10, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY WITH DISTAL FEMUR REPLACEMENT AND REMOVAL OF DEEP IMPLANT PLATES & SCREWS FOLLOWING NON-UNION OF FEMUR FRACTURE. TWO DAYS POST IMPLANTATION, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO CORRECT OMISSION OF THE POLY INSERT DURING INITIAL PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16133118 ↗
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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