NexGen® 00-5901-033-00Recalls & reported problems
Zimmer, Inc. · Class 1
All models of NexGen (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024201675), received between Aug 3, 2022 and Dec 5, 2025 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Fracture” (17 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
- Fracture17
Patient problems
- No Clinical Signs, Symptoms or Conditions17
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2025Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23728526 ↗MalfunctionOct 30, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23423975 ↗MalfunctionFeb 4, 2025Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21303863 ↗MalfunctionJan 7, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING IMPACTION OF FINAL TIBIAL IMPLANT, IMPACTOR HEAD BROKE IN 2. NOMISSING PIECES, SURGEON LOOKED INTO PATIENT, DIDN¿T FIND ANYTHING IN PATIENT OR ON STERILE DRAPES. NO HARM OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21095319 ↗MalfunctionNov 4, 2024Fracture; Fracture
NO ADDITIONAL INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20602008 ↗MalfunctionSep 25, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20301307 ↗MalfunctionSep 3, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. NO MORE INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20128565 ↗MalfunctionApr 22, 2024Fracture; Fracture
NO ADDITIONAL INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19160189 ↗MalfunctionApr 22, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE TIBIAL IMPACTOR HEAD FRACTURED. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159986 ↗MalfunctionApr 22, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE TIBIAL IMPACTOR HEAD FRACTURED. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159980 ↗MalfunctionApr 19, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE TIBIAL IMPACTOR HEAD FRACTURED. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19143171 ↗MalfunctionApr 2, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR FRACTURED DURING USE AS PART OF A KNEE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19020065 ↗MalfunctionApr 1, 2024Fracture; Fracture
IT WAS REPORTED THAT AN IMPACTOR FRACTURED DURING PLACEMENT OF THE TIBIA PROSTHESIS AS PART OF A KNEE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19012481 ↗MalfunctionJan 18, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE PROCEDURE, A TIBIAL IMPACTOR INSTRUMENT FRACTURED. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18537305 ↗MalfunctionFeb 15, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16379235 ↗MalfunctionJan 11, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16137661 ↗MalfunctionAug 3, 2022Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15155751 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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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