P.F.C. SIGMA RPF 95-0024Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 3 RIGHT · Class 3 · Implant
All models of P.F.C. SIGMA RPF (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295224105), received between Oct 4, 2018 and May 6, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Loss of or Failure to Bond1
Patient problems
- No Code Available2
- Pain2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT ON (B)(6), 2010, THE PATIENT UNDERWENT A TKA SURGERY WITH THE IMPLANTS IN QUESTION. AFTER SURGERY, ON UNKNOWN DATE, LOOSENING OF IMPLANTS WAS CONFIRMED. ON (B)(6), 2022, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, THE IMPLANTS WERE EXTRACTED AND REPLACED WITH COMPETITOR¿S IMPLANTS. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2010. DOR: (B)(6) 2022 UNKNOWN KNEE.
Patient problems: Insufficient Information
MAUDE report 14304170 ↗InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 4, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE.
Patient problems: No Code Available; Pain
MAUDE report 7934276 ↗
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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