SIGMA AOX 1961-92-134Recalls & reported problems
Depuy Orthopaedics, Inc. · SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 3 17.5mm · Class 3 · Implant
All models of SIGMA AOX (53)
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 10603295076544), received between Apr 16, 2021 and Jul 29, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Naturally Worn1
Patient problems
- Insufficient Information1
- Joint Laxity1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2025Fracture; Naturally Worn; Fracture; Naturally Worn
ADDITIONAL INFORMATION RECEIVED STATES THAT THE IMPLANT IS WORN THEREFORE UNABLE TO READ THE LOT NUMBER.
Patient problems: Insufficient Information
MAUDE report 22647983 ↗InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A SIGMA TOTAL KNEE DONE ON (B)(6) 2019 AND A REVISION OF TIBIAL COMPONENT ON (B)(6) 2020 (NO DER RECORD IN THE SYSTEM). THE PATIENT COMPLAINT OF PAIN AND INSTABILITY WITH KNEE "GIVING OUT". THE FEMORAL AND THE TIBIAL COMPONENTS WERE REMOVED AND AN ATTUNE REVISION WAS PERFORMED. DOI: (B)(6) 2019. 1ST REVISION: (B)(6) 2020 TIBIAL COMPONENT). 2ND REVISION: (B)(6) 2021 (FEMORAL AND TIBIAL COMPONENTS); LEFT KNEE.
Patient problems: Joint Laxity; Pain
MAUDE report 11680485 ↗
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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