OXFORD PARTIAL KNEE SYSTEMFEMORAL SLAP HAMMER 32-422365Recalls & reported problems
Biomet Uk Ltd · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet Oxford Partial Knee System femoral slap hammer is a hand surgical instrument used during knee replacement surgery. The 71 reports mostly describe the internal spring fracturing or breaking, either during surgery or found when the instrument was being set up, sometimes leaving small pieces on the operating table. Reports mention 70 malfunctions, one injury and no deaths, and no recalls name this device.
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
- 65
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 05019279129751), received between Jul 1, 2019 and Jul 8, 2026 — classified as 1 injury, 64 malfunctions.
The most frequently reported specific device problem is “Fracture” (54 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
- Fracture54
- Break5
- Material Integrity Problem3
- Mechanical Jam2
- Mechanical Problem2
- Difficult to Insert1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions61
- Foreign Body In Patient3
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25747927 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT, DURING A SURGICAL PROCEDURE, THE SPRING OF THE FEMORAL SLAP HAMMER FRACTURED, RESULTING IN LOSS OF RETENTION AND RENDERING THE INSTRUMENT UNUSABLE. THERE WERE NO ADVERSE CONSEQUENCES OR HEALTH IMPACTS TO THE PATIENT, AND NO DEBRIS WAS RETAINED IN OR FELL INTO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25199709 ↗MalfunctionApr 27, 2026Fracture
IT WAS REPORTED THAT, PRIOR TO CLINICAL USE OR EXPOSURE, TWO FEMORAL SLAP HAMMERS WERE FOUND TO HAVE BROKEN SPRINGS. THE PROCEDURE WAS SUBSEQUENTLY PERFORMED USING A BACKUP INSTRUMENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003363 ↗MalfunctionApr 27, 2026Fracture
IT WAS REPORTED THAT, PRIOR TO CLINICAL USE OR EXPOSURE, TWO FEMORAL SLAP HAMMERS WERE FOUND TO HAVE BROKEN SPRINGS. THE PROCEDURE WAS SUBSEQUENTLY PERFORMED USING A BACKUP INSTRUMENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25003353 ↗MalfunctionApr 9, 2026Fracture
IT WAS REPORTED THAT STERILIZATION STAFF NOTICED A SLAP HAMMER WAS BROKEN AFTER A CASE. THE BREAKAGE WAS IDENTIFIED DURING POST-PROCEDURE PROCESSING. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. UPON PRODUCT RETURN IT WAS IDENTIFIED THAT THE SPRING WAS FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825998 ↗MalfunctionFeb 12, 2026Difficult to Insert
IT WAS REPORTED DURING A SURGERY, THE FEMORAL SLAP HAMMER COULD NOT HOLD ONTO THE TRIAL FEMORAL IMPLANT. THE HANDLE FELT LOOSE. A BACK-UP INSTRUMENT WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTED HEALTH CONSEQUENCES OR IMPACTS TO THE PATIENT. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322118 ↗MalfunctionJan 26, 2026Fracture
IT WAS REPORTED THAT DURING SURGERY THE SPRING BETWEEN THE TWO CLAWS OF THE INSTRUMENT BROKE, AND THE PROCEDURE WAS COMPLETED WITH THE SAME INSTRUMENT. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176034 ↗MalfunctionJan 13, 2026Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE SLAP HAMMER BROKE. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY USING ANOTHER DEVICE. THE BROKEN DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053597 ↗MalfunctionJan 13, 2026Mechanical Jam
IT WAS REPORTED THAT DURING SURGERY THE CLAMPS COULD NOT SPRING BACK TO SECURE THE SINGLE-COLUMN MOLD WHEN REMOVAL WAS ATTEMPTED, AND MANUAL SPRINGBACK WAS USED TO REMOVE THE MOLD AND SOME TOOLS. THE SURGEON ABLE TO COMPLETE THE SURGERY WITH ANOTHER DEVICE. THE BROKEN DEVICE DOES NOT CONTACT WITH THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24053197 ↗MalfunctionJan 13, 2026Fracture
IT WAS REPORTED THAT THE FEMORAL SLAP HAMMER WAS DAMAGED AND THAT THE EXTRACTOR SPRING WAS ALSO DAMAGED. THE DAMAGE WAS NOTICED WHILE PREPARING THE INSTRUMENTS FOR STERILIZATION, NOT DURING SURGERY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052344 ↗MalfunctionJan 12, 2026Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE SPRING OF THE FEMORAL SLAP HAMMER FRACTURED. NO FOREIGN MATERIALS WERE RETAINED IN THE PATIENT, AND THERE WERE NO REPORTED CONSEQUENCES OR IMPACTS TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24035469 ↗MalfunctionDec 19, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23852092 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE SPRING OF THE FEMORAL SLAP HAMMER FRACTURED, RENDERING THE INSTRUMENT UNUSABLE FOR REMOVING THE GUIDES. THE ISSUE WAS IDENTIFIED OUTSIDE OF A CLINICAL SETTING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837316 ↗MalfunctionDec 16, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE SPRING OF THE FEMORAL SLAP HAMMER FRACTURED WHILE REMOVING A TRIAL. ALL FRAGMENTS WERE RECOVERED AND ACCOUNTED FOR, AND THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL INSTRUMENTATION. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23814163 ↗MalfunctionDec 11, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING THE CLEANING/STERILIZATION PROCESS, THE FEMORAL SLAP HAMMER WAS NOTED TO BE DEFECTIVE. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777804 ↗MalfunctionNov 10, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23508466 ↗MalfunctionOct 15, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE USING A SLAP HAMMER DURING THE SURGERY, THE SURGEON NOTICED IT WAS BROKEN. THE SPRING INSIDE NO LONGER WORKED. HE STILL USED IT FOR THE CASE. THERE WAS NO IMPACT TO THE PATIENT, NO FOREIGN BODY RETAINED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23297946 ↗MalfunctionOct 15, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279704 ↗MalfunctionJul 22, 2025Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT CAME OUT OF THE WASH WITH FRACTURED SPRING. IT WAS FUNCTIONAL DURING THE CASE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563093 ↗MalfunctionJul 14, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL SLAP HAMMER BROKE DURING A SURGICAL PROCEDURE. NO FOREIGN BODY WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED HEALTH IMPACT OR COMPLICATION TO THE PATIENT OR OPERATOR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22492265 ↗MalfunctionJul 9, 2025Fracture; Fracture
IT WAS REPORTED THAT AFTER THE OPERATION, AT THE STAGE OF CLEANING, THE STERILE PERSONNEL NOTICED THAT THE SPRING HAD BROKEN ON THE INSTRUMENT. NOTHING WAS NOTICED DURING THE OPERATION, SO THERE WAS NO DELAY OR HARM TO THE PATIENT. THE INSTRUMENT WAS USED AS DESCRIBED IN THE SURGICAL TECHNIQUE. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22455774 ↗MalfunctionJun 2, 2025Fracture; Fracture
IT WAS REPORTED THAT JUST BEFORE THE FEMORAL SLAP HAMMER WAS TO BE USED, THE HEALTHCARE PROFESSIONAL OBSERVED THAT THE SPRING COMPONENT OF THE INSTRUMENT HAD BROKEN INTO TWO PARTS. IT REMAINS UNCLEAR WHETHER THE SPRING BROKE DURING CLEANING AFTER THE PREVIOUS PROCEDURE OR DURING USE. A REPLACEMENT INSTRUMENT WAS UTILIZED, AND THERE WAS NO IMPACT ON THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22124512 ↗MalfunctionMay 22, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY THE SLAP HAMMER SPRING BROKE. THERE WAS NO IMPACT TO THE PATIENT, NO FOREIGN BODY WAS RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069019 ↗MalfunctionMay 14, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22017505 ↗MalfunctionMay 8, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED DURING A PROCEDURE THAT THE SPRING AT THE DISTAL PART OF THE DEVICE WAS LOOSE, NO HARM TO PATIENT. IT IS UNKNOWN HOW MANY TIMES THE DEVICES WERE USED, SURGERY WAS COMPLETED WITH ANOTHER DEVICE. EVALUATION OF THE DEVICE LATER FOUND THAT THE SPRING WAS FRACTURED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21988758 ↗
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.
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