P.F.C. SIGMA 96-2143Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED 4 (STAB) 15mm 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 tibial insert is a plastic part used in knee replacement. Reports mostly describe follow-up surgeries for pain, looseness or instability, wear and infection. There are 25 reports naming its identifier, with no deaths and 24 injuries. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295241331), received between Nov 6, 2017 and Dec 5, 2025 — classified as 24 injuries, 1 malfunction.
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 Problem16
- Insufficient Device Problem Information5
- Naturally Worn2
- Fracture1
- Missing Information1
Patient problems
- No Code Available12
- Pain9
- Unspecified Infection7
- Not Applicable3
- Joint Laxity2
- Scar Tissue2
- Fall1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAVING SLIGHT INSTABILITY BILATERALLY. PATELLA REVISION AND POLY EXCHANGE PERFORMED BILATERALLY. NO DELAYS, NO ADVERSE PATIENT CONSEQUENCES. DOI- (B)(6) 2009, DOR- (B)(6) 2025, AFFECTED SIDE- LEFT KNEE.
Patient problems: Joint Laxity
MAUDE report 23730203 ↗InjuryJul 25, 2024Naturally Worn; Naturally Worn
A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO TIBIAL TRAY LOOSENING AND POLY WEAR. TIBIAL TRAY SHOWED NO CEMENT REMAINING. UNKNOWN CEMENT MFG.
Patient problems: Insufficient Information
MAUDE report 19833318 ↗InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAINFUL KNEE FROM SCAR TISSUE. DOI: (B)(6) 2010; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.
Patient problems: Pain; Scar Tissue
MAUDE report 18517130 ↗InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO LYTIC LESION NEAR THE TIBIAL IMPLANT. THERE WAS A LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. DOI: 15 YEARS AGO; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.
Patient problems: Osteolysis; Unspecified Tissue Injury
MAUDE report 14713109 ↗InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAINFUL KNEE. DID SCAR EXCISION. AND NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.
Patient problems: Pain; Scar Tissue
MAUDE report 13568065 ↗InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO DEVELOPED SOME LAXITY. A POLY EXCHANGE WAS SUCCESSFULLY PERFORMED. NO WEAR WAS NOTED NOR MALALIGNMENT WAS PRESENT AND JOINT LINE WAS APPROPRIATE. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT KNEE.
Patient problems: Joint Laxity
MAUDE report 12923024 ↗InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2007. DATE OF REVISION: (B)(6) 2008; (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10861925 ↗InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. A POLY EXCHANGE WAS DONE AND NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.
Patient problems: No Code Available
MAUDE report 10845144 ↗MalfunctionNov 12, 2020Missing Information; Missing Information
CASE MISSING LABELS FOR PATIENT. NO PROBLEMS OTHERWISE. NO DELAYS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10829548 ↗InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED TO ADDRESSED INSTABILITY. PATIENT WAS LOOSE IN BOTH FLEXION AND EXTENSION AND WAS UPSIZED FROM A 15MM TO A 20MM POLY. POLY SWAP WAS DONE. DOI: 2015, DOR: (B)(6) 2020, RIGHT KNEE.
Patient problems: Limited Mobility Of The Implanted Joint
MAUDE report 10795299 ↗InjuryApr 13, 2020Fracture; Fracture
InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS UNSTABLE PAINFUL KNEE. DOI: (B)(6) 2008; DOR: (B)(6) 2019 RIGHT KNEE.
Patient problems: No Code Available; Pain
MAUDE report 9538970 ↗InjuryNov 22, 2019Naturally Worn; Naturally Worn
PATIENT WAS REVISED TO ADDRESS INSTABILITY. POLY WAS CHANGED FROM 10MM TO 15MM. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.
Patient problems: No Code Available
MAUDE report 9362263 ↗InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
1ST STAGE REVISION DUE TO PERI PROSTHETIC INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8901919 ↗InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019; RIGHT KNEE.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8707569 ↗InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD FLUID PULLED OFF THE KNEE AND RESULTS SHOWED AN INFECTIOUS ORGANISM. SURGEON BROUGHT PATIENT TO OR TO PERFORM A POLY SWAP WITH PLACEMENT OF ANTIBIOTIC BEADS. SURGEON DID USE BACTISURE AND MECHANICAL SCRUB OF METAL IMPLANTS. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8680131 ↗InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS PAIN DUE TO INSTABILITY. DOI: 2008. DOR: (B)(6) 2019. LEFT KNEE.
Patient problems: No Code Available; Pain
MAUDE report 8399674 ↗InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2018 I&D WAS PERFORMED, PATIENT WAS ASPIRATED AT THAT TIME WITH STAPH AUREUS. ON (B)(6) 2018, THE SURGEON PERFORMED A LINER EXCHANGE. DOI: (B)(6) 2010. DOR: (B)(6) 2018. LEFT KNEE.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8336382 ↗InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS INFECTION. WASHED OUT AND THE INSERT EXCHANGED WAS DONE. DOI: (B)(6) 2018. DOR: (B)(6) 2019; RIGHT KNEE.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8315644 ↗InjuryJun 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. DOI: (B)(6) 2014 DOR: (B)(6) 2018 RIGHT KNEE.
Patient problems: Not Applicable; Pain
MAUDE report 7629309 ↗InjuryJun 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WAS REVISED TO ADDRESS PAIN WHEN WALKING. DOI: (B)(6) 2016 DOR: (B)(6) 2018 LEFT KNEE.
Patient problems: No Code Available; Not Applicable; Pain
MAUDE report 7564795 ↗InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT ID #: (B)(6). CLINICAL NOTIFICATION FOR REVISION OF INSERT DUE TO LEFT TOTAL KNEE PAIN WITH FLEXION CONTRACTURE RECEIVED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; (LEFT KNEE).
Patient problems: Not Applicable; Pain
MAUDE report 7544347 ↗InjuryFeb 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WAS REVISED TO ADDRESS INFECTION. (B)(6) 2017; (B)(6) 2018; LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 7236889 ↗InjuryNov 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
DER STATES THAT THE PATIENT HAD PAINFUL KNEE WITH LIMITED RANGE OF MOTION. SURGEON EXPLANTED 15 MM INSERT AND DOWNSIZED TO A 10 MM INSERT.
Patient problems: Pain
MAUDE report 7053342 ↗InjuryNov 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
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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