NexGen® 00-5901-032-00Recalls & reported problems
Zimmer, Inc. · Class 1
All models of NexGen (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer NexGen femoral impactor is a manual surgical tool used during knee replacement procedures to seat the implant. FDA records show 25 malfunction reports and no deaths or injuries. The reports describe the impactor pad or block breaking in half during surgery, typically without fragments entering the patient and without surgical delays. No recalls name this device. Report volume has been lower in the most recent 12 months (4 reports) than the prior period (10 reports).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024201668), received between Oct 28, 2020 and Jul 13, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Fracture” (23 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
- Fracture23
- Break1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25800057 ↗MalfunctionDec 10, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY, AFTER PLACEMENT OF THE DEFINITIVE IMPLANT, THE SURGEON IMPACTED TO ADJUST THE IMPLANT AND THE FEMORAL IMPACTOR BROKE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. THE IMPLANT REMAINED INTACT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23769411 ↗MalfunctionDec 2, 2025Fracture; Fracture
IT WAS REPORTED THAT AN IMPACTOR PAD BROKE DURING SURGERY. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY. THERE WERE NO FOREIGN BODIES RETAINED. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693379 ↗MalfunctionOct 31, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437588 ↗MalfunctionOct 28, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE FEMORAL IMPACTOR BLOCK FRACTURED. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. BACKUP INSTRUMENTATION WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405600 ↗MalfunctionOct 28, 2025Crack; Fracture; Crack; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405518 ↗MalfunctionOct 17, 2025Fracture; Fracture
IT WAS REPORTED THE FEMORAL IMPACTOR BROKE DURING IMPACTION. NO PATIENT HARM OR IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322594 ↗MalfunctionOct 1, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23189750 ↗MalfunctionSep 16, 2025Fracture; Fracture
IT WAS REPORTED THAT AN IMPACTOR WAS FOUND BROKEN BY SPD BEFORE STERILIZING. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND ALL HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23062233 ↗MalfunctionJul 1, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE IMPACTOR BROKE WHEN THE SURGEON GAVE THE FINAL BLOW DURING IMPACTION OF THE DEFINITIVE FEMORAL COMPONENT. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22371711 ↗MalfunctionJun 30, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR BROKE DURING IMPACTION. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22356703 ↗MalfunctionMar 7, 2025Fracture; Fracture
IT WAS REPORTED THAT THE FEMORAL IMPACTOR BROKE IN SURGERY. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. THE SURGERY WAS COMPLETED WITH A SECOND DEVICE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547137 ↗MalfunctionJan 28, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21255379 ↗MalfunctionAug 22, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20030103 ↗MalfunctionAug 2, 2024Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR HEAD FRACTURED DURING REMOVAL OF A TRIAL 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 19892730 ↗MalfunctionJun 17, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19552225 ↗MalfunctionApr 2, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE USING THE FEMORAL IMPACTOR, THE FEMORAL IMPACTOR BLOCK BROKE IN HALF. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. THERE WAS NO PATIENT HARM. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19020569 ↗MalfunctionOct 16, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE PROCEDURE, THE HEAD OF THE IMPACTING INSTRUMENT FRACTURED DURING FEMORAL IMPLANTATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE. THERE WAS NO PATIENT IMPACT OR ADVERSE EVENTS AS A RESULT OF THE MALFUNCTION. DILIGENCE IS IN PROCESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17938968 ↗MalfunctionJun 14, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17127144 ↗MalfunctionNov 8, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING THE IMPACTING OF THE FEMUR, THE BLACK FEMORAL IMPACTOR BLOCK BROKE. NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15752637 ↗MalfunctionSep 16, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING KNEE ARTHROPLASTY, THE FEMORAL IMPACTOR FRACTURED WHEN IT WAS IMPACTED WITH A HAMMER. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15436979 ↗MalfunctionMar 3, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING KNEE ARTHROPLASTY A CRACK WAS IDENTIFIED IN THE TIBIAL ARTICULAR SURFACE PROVISIONAL PRIOR TO TRIALING AND THE FEMORAL IMPACTOR FRACTURED IN HALF UPON IMPACTION WITH THE FEMUR. ADDITIONAL INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13661297 ↗MalfunctionMay 28, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11900785 ↗MalfunctionOct 28, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10750887 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page