P.F.C. SIGMA 96-2121Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED 2.5 (STAB) 10mm GVF · Class 3 · Implant
All models of P.F.C. SIGMA (487)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy P.F.C. Sigma knee implant tibial insert has 42 adverse event reports naming its identifier, all involving injuries and no deaths. Reports mostly describe patients needing revision surgery because of loosening, instability, pain, or possible infection. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10603295241171), received between Oct 25, 2016 and May 4, 2026 — classified as 42 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).
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 Problem32
- Insufficient Device Problem Information5
- Naturally Worn4
- Fracture1
- Patient-Device Incompatibility1
Patient problems
- Pain25
- No Code Available21
- Joint Laxity6
- Unspecified Infection5
- Not Applicable4
- Insufficient Information2
- Muscular Rigidity2
- Synovitis2
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT INFECTED KNEE WITH LOOSENING. AFFECTED SIDE-LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 25070690 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY EXCHANGE DUE TO STABILITY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.
Patient problems: Joint Laxity
MAUDE report 24674156 ↗InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE, AND ALSO HAD POSSIBLE INFECTION. SURGEON PERFORMED I&D AND WENT WITH THICKER POLY. INFECTION WAS NOT CONFIRMED. AFFECTED SIDE: LEFT KNEE.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 22203322 ↗InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD GOOD RANGE OF MOTION, BUT RECENTLY TIGHTENED UP. SYNOVECTOMY AND POLY EXCHANGE WERE PERFORMED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.
Patient problems: Muscular Rigidity
MAUDE report 21142804 ↗InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED WITH POLY DUE TO PAIN. DOI: (B)(6) 2006. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Pain
MAUDE report 20854293 ↗InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT I&D WITH POLY SWAP WAS PERFORMED; INDEX SURGERY DATE AND HOSPITAL ARE UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 18887685 ↗InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2010. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Joint Laxity
MAUDE report 18356837 ↗InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED FOR INSTABILITY, WENT UP FROM 10MM TO 12.5MM. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE- UNKNOWN KNEE.
Patient problems: Joint Laxity
MAUDE report 17886489 ↗InjuryApr 10, 2023Naturally Worn; Naturally Worn
PATIENT WAS REVISED DUE TO SLIGHT POLY WEAR. DOI: (B)(6) 2011, DOR: (B)(6) 2023, AFFECTED SIDE- RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 16706797 ↗InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION COMPLETED DUE TO INSTABILITY. DOI: (B)(6) 2011; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.
Patient problems: Joint Laxity
MAUDE report 13720681 ↗InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAINFUL LEFT KNEE. DOI: (B)(6) 2021. DOR: (B)(6) 2021, (LEFT KNEE).
Patient problems: Pain
MAUDE report 12531922 ↗InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY. POLY EXCHANGE WAS DONE AND NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.
Patient problems: Joint Laxity
MAUDE report 12376671 ↗InjuryAug 5, 2021Fracture; Fracture
PATIENT WAS REVISED DUE TO EXPERIENCING SIGNIFICANT PAIN RECENTLY. SIGMA PATELLA HAD SIGNIFICANT WEAR AND POLY WAS CRACKED. REPLACED ALL COMPONENTS WITH ATTUNE REVISION. DOI: (B)(6) 2008 DOR: (B)(6) 2021 LEFT KNEE.
Patient problems: Pain
MAUDE report 12283859 ↗InjuryDec 30, 2020Naturally Worn; Naturally Worn
THE PATIENT WAS REVISED TO ADDRESS PAIN AND POLY WEAR-INDUCED SYNOVITIS. THE PATIENT'S PRIMARY SIGMA FB RP KNEE COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. DOI: (B)(6) 2009, DOR: (B)(6) 2020, RIGHT KNEE.
Patient problems: Pain; Synovitis
MAUDE report 11093191 ↗InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS COMPLAINED OF PATELLA PAIN. SUSPECTED AVN OF THE PATELLA. SURGEON PERFORMED A PATELLECTOMY AND REPLACED POLY WHILE HE WAS IN THERE. DOI: (B)(6) 2016; DOR: (B)(6) 2020; RIGHT KNEE.
Patient problems: Pain
MAUDE report 10889542 ↗InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO TIGHT FLEXION. DOI: (B)(6) 2012, DOR: (B)(6) 2020 LEFT KNEE.
Patient problems: Limited Mobility Of The Implanted Joint; No Code Available
MAUDE report 10542046 ↗InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2020, LEFT KNEE.
Patient problems: No Code Available; Pain
MAUDE report 10189962 ↗InjuryMar 18, 2020Naturally Worn; Naturally Worn
IT WAS REPORTED THE PATIENT HAD A POLY EXCHANGE DUE TO PLOY WEAR. DOI: (B)(6) 2007; DOR: (B)(6) 2020; RIGHT KNEE.
Patient problems: No Code Available
MAUDE report 9849077 ↗InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RIGHT KNEE REVISION; ORIGINAL SURGERY DONE (B)(6) 2015. PATIENT COMPLAINED OF STIFFNESS AND ANTERIOR PAIN. REMOVED POLY, TRAY AND FEMUR.
Patient problems: Muscular Rigidity; No Code Available; Pain
MAUDE report 9834958 ↗InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OF RIGHT TKA DUE TO PATIENT PAIN.
Patient problems: No Code Available; Pain
MAUDE report 9758157 ↗InjuryJan 9, 2020Naturally Worn; Naturally Worn
THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE COMPETITIVE REVISION SURGEON AND THE ORIGINAL SURGEON WERE SOMEWHAT SHOCKED AT THE AMOUNT OF WEAR, PITTING AND BACKSIDE WEAR. THE SURGEON WOULD LIKE A FOLLOW UP LETTER REGARDING ANY FINDINGS ON THE TIBIAL INSERT. DOI: (B)(6) 2015. DOR: (B)(6) 2019, LEFT KNEE.
Patient problems: No Code Available; Osteolysis; Pain; Synovitis
MAUDE report 9570010 ↗InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. PREVIOUS SURGICAL DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.
Patient problems: No Code Available; Pain
MAUDE report 9413089 ↗InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. PREVIOUS SURGERY DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.
Patient problems: No Code Available; Pain
MAUDE report 9412065 ↗InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2019 LEFT KNEE.
Patient problems: No Code Available; Pain
MAUDE report 9297459 ↗InjuryNov 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS PAIN. DOI: 2012; DOR: (B)(6) 2019; RIGHT KNEE.
Patient problems: No Code Available; Pain
MAUDE report 9292636 ↗
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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