SIGMA 1960-30-600Recalls & reported problems
Depuy (Ireland) · SIGMA FEMORAL CR150 CEMENTED SIZE 6 RIGHT · Class 3 · Implant
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295074991), received between May 23, 2022 and May 23, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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.
Most reported problems
Device problems
- Migration1
Patient problems
- Bone Fracture(s)1
- Joint Laxity1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2022Migration; Migration
PRIMARY CR150 MBT TKJA IN SITU - IMPLANTED (B)(6) 2017, PATIENTS HAS CONSISTENTLY COMPLAINED ABOUT PAIN AND INSTABILITY. ON X-RAY - IMPLANTS APPEAR WELL FIXED WITH SOME FOREIGN LOOSE BODIES NOTED POSTERIOR KNEE AND NATIVE PATELLA - FEMUR AND TIBIA APPEAR IN VARUS POSITION AND FEMUR HAS FLEXED. PLAN WAS TO OPEN AND REMOVE LOOSE BODIES AND RESURFACE PATELLA WITH ? FULL ATTUNE REVISION . PRIMARY IMPLANTS EXPLANTED AND FULL ATTUNE REVISION PERFORMED. FEMUR - SIZE 8 RIGHT WITH 18X60MM PRESSFIT STEM AND 40MM PARTIALLY COATED SLEEVE. 4MM DISTAL AUGMENTS MEDIALLY AND LATERALLY. TIBIA - SIZE 7 REVISION RP BASE WITH 14X60MM PRESSFIT STEM, 37MM PARTIALLY COATED SLEEVE POLY - 8/10MM REVISION INSERT.
Patient problems: Bone Fracture(s); Joint Laxity; Pain
MAUDE report 14468693 ↗
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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