NA 1294-56-141Recalls & reported problems
Depuy (Ireland) · M.B.T. REVISION STEP WEDGE SIZE 5 10mm CEMENTED · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295026785), received between Jan 24, 2022 and Aug 7, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).
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
- Loss of or Failure to Bond1
- Migration1
Patient problems
- Discomfort1
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Loss of or Failure to Bond
Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Dartmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysis.Reason for revision: Revision due to loose tibia. The non-articular surface of the cemented tibial tray shows moderate cement remaining. Loosening interface not included.
Patient problems: Insufficient Information
MAUDE report 50173974 ↗InjuryJan 24, 2022Migration; Migration
THE PATIENT WAS REVISED DUE TO TIBIA COLLAPSED ON THE MEDIAL SIDE AND CAUSED PATIENT DISCOMFORT AND INSTABILITY. THE DOCTOR REMOVED ALL COMPONENTS AND REPLACED WITH A NEW REVISION KNEE TO CORRECT PATIENTS INSTABILITY. DOI : (B)(6) 2008 DOR : (B)(6) 2022 LEFT SIDE.
Patient problems: Discomfort; Joint Laxity
MAUDE report 13335033 ↗
Other Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices
- ATTUNE 1506-10-005Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing442 reports
- ATTUNE 1506-10-004Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing442 reports
- ATTUNE 1518-20-038Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing3 deaths393 reports
- LCS SIGMA 1294-33-130Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 recall310 reports
- ATTUNE 1518-20-035Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing342 reports
- P.F.C. SIGMA 96-0102Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 death319 reports
- ATTUNE 1518-20-041Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing308 reports
- ATTUNE 1506-10-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing284 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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