P.F.C. SIGMA RPF 95-0010Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 1 LEFT · 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
- 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 10603295223986), received between Aug 15, 2022 and Aug 15, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Loss of or Failure to Bond1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2022Loss of or Failure to Bond; Loss of or Failure to Bond
THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THAT THE TIBIAL IMPLANTS WERE LOOSENED AFTER THE PRIMARY SURGERY. THIS PC REPORTS THAT THE FEMORAL IMPLANTS WERE LOOSENED AFTER THE REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE REVISION SURGERY (THE TKA). THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE FEMORAL IMPLANTS WERE LOOSENED. THEREFORE, THE SECOND REVISION SURGERY (THE TKA) WAS PERFORMED ON (B)(6) 2022. THE RPF WAS REPLACED WITH THE PS STEM AND THE AUGMENTATION, AND THE 12.5MM RPF INSERT WAS REPLACED WITH THE 12.5MM STAB INSERT. ACCORDING TO THE SURGEON, THE CAUSE OF THE LOOSENING WAS DE-BONDING. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15224852 ↗
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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