MORELAND 2422-12-000Recalls & reported problems
Depuy Orthopaedics, Inc. · MORELAND REV INST CUP CHISEL 56mm 80 DEGREES · Class 1
All models of MORELAND (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295123095), received between Dec 14, 2017 and Jun 18, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- 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.
MalfunctionJun 18, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE BREAKDOWN DUE TO NATURAL WEAR AND TEAR!
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283960 ↗MalfunctionMar 16, 2021Break; Break
IN REMOVING AN ACETABULAR SHELL FOR SCHEDULED REVISION, SURGEON BROKE TWO (2) CURVED OSTEOTOMES FROM OUR LOAN MORELANDS CEMENTLESS REMOVAL INSTRUMENTS KIT. IN EACH INSTANCE, THE TIP OF THE OSTEOTOME SNAPPED, LIKELY DUE TO BEING USED AS A LEVER BEHIND THE ACETABULAR SHELL. PRODUCT CODES D242212000 & D2422-13. METAL FRAGMENT WAS A SINGLE PIECE ON EACH OCCASION AND WAS EASILY RETRIEVED FROM THE PATIENT WITH NO PATIENT HARM OR IMPACT ON SURGICAL TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11495682 ↗MalfunctionDec 14, 2017Break; Break
IT WAS REPORTED THAT BOTH ACETABULAR CUP OSTEOTOMES BROKE DURING USE AND TIPS AND STEM IMPACTORS WERE ALSO BROKEN DURING IMPACTION. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7118097 ↗
Other OSTEOTOME devices
- NA 2598-07-530Depuy (Ireland) · OSTEOTOME86 reports
- NA 2002-31-000Depuy (Ireland) · OSTEOTOME61 reports
- Watson Extraction System 17601Depuy (Ireland) · Osteotome60 reports
- MORELAND 2422-10-000Depuy Orthopaedics, Inc. · OSTEOTOME53 reports
- SIGMA 2024-47-111Depuy (Ireland) · OSTEOTOME43 reports
- Watson Extraction System 17001Depuy (Ireland) · Osteotome41 reports
- CS-PLUS/CSL-PLUS 75002165Smith & Nephew, Inc. · OSTEOTOME35 reports
- NA 2002-25-000Depuy (Ireland) · OSTEOTOME31 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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