INSTRUMENT 1020-5205Recalls & reported problems
Howmedica Osteonics Corp. · ACCOLADE II BROACH · Class 2
All models of INSTRUMENT (131)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327252705), received between Jun 5, 2018 and Jul 24, 2025 — classified as 1 injury, 2 malfunctions.
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
- Delamination1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2025Fracture; Fracture
DISTRIBUTOR REPORT: "THE ATTACHMENT POLE OF THE ACCOLADE II RASP NO. 5 BROKE OFF DURING IMPACTION. THE RASP WAS REMOVED AND ANOTHER SET WAS OPENED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586282 ↗InjuryJun 17, 2022Fracture; Fracture
IT WAS REPORTED THAT THE BROACH HANDLE ATTACHMENT POST ON SIZE 5 ACCOLADE 2 BROACH SNAPPED OFF OF THE BROACH AND WAS STUCK IN HANDLE. OSTEOTOMES AND VICE GRIPS WERE USED REPEATEDLY TO EVENTUALLY REMOVE THE BROACH FROM THE FEMORAL CANAL. SURGERY TOOK ROUGHLY AN ADDITIONAL HOUR TO COMPLETE AND SURGEON HAD TO REMOVE SOME QUALITY BONE FROM PATIENT¿S FEMUR.
Patient problems: Foreign Body In Patient
MAUDE report 14731188 ↗MalfunctionJun 5, 2018Fracture; Delamination; Fracture; Delamination
COLOR MARKING FROM THE RASPS CRUMBLE OFF. REPLACEMENT WAS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7569352 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 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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