NA 00-5850-020-12Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024195684), received between Jan 22, 2020 and Nov 5, 2025 — classified as 8 injuries.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
- Adverse Event Without Identified Device or Use Problem2
- Unstable2
- Insufficient Device Problem Information1
- Material Erosion1
- Naturally Worn1
Patient problems
- Failure of Implant3
- Pain3
- Fall2
- Cancer1
- Damage to Ligament(s)1
- Insufficient Information1
- Joint Laxity1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
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 23478628 ↗InjuryAug 25, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 6 MONTHS POST-OP, THE PATIENT PRESENTED WITH VARUS/VALGUS LAXITY, INSTABILITY, AND PAIN. X-RAY FINDINGS NOTED APPARENT METAL DEBRIS. SUBSEQUENTLY, THE PATIENT WAS REVISED. UPON OPENING THE JOINT SPACE, IT WAS DISCOVERED THAT A PIECE OF THE METAL BUSHING/POST HAD BROKEN OFF AND THE METAL DEBRIS WERE METAL HINGE FRAGMENTS. THE POLY WAS UPSIZED AND THE FEMORAL COMPONENT WAS REPLACED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Laxity; Pain
MAUDE report 22882745 ↗InjuryJun 19, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY EIGHT (8) MONTHS POST-IMPLANTATION DUE TO A BROKEN ZSS POST ON THE POLY AND A BROKEN CEMENT SHIELD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 19566029 ↗InjuryJan 10, 2023Material Erosion; Unstable; Material Erosion; Unstable
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Cancer; Failure of Implant; Fall; Pain; Swelling/ Edema
MAUDE report 16130596 ↗InjuryAug 3, 2022Fracture; Fracture
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY NINE MONTHS POST IMPLANTATION DUE TO IMPLANT FRACTURE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 15159459 ↗InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 11059446 ↗InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Damage to Ligament(s)
MAUDE report 9811391 ↗InjuryJan 22, 2020Unstable; Naturally Worn; Unstable; Naturally Worn
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Fall; Pain
MAUDE report 9616030 ↗
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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