P.F.C. SIGMARecalls & reported problems across all models
Depuy Orthopaedics, Inc. · 18 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 89
- Deaths reported
- 0
- Injuries reported
- 69
- Recalls
- 0
We found 18 models of P.F.C. SIGMA by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 89 adverse event reports in the FDA's MAUDE database, received between Jul 21, 2017 and Dec 22, 2025 — classified as 69 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported P.F.C. SIGMA problems
Device problems
- Loss of or Failure to Bond35
- Adverse Event Without Identified Device or Use Problem19
- Device-Device Incompatibility12
- Migration4
- Appropriate Device Problem Term/Code Not Available3
- Break3
- Loose or Intermittent Connection3
- Fracture2
Patient problems
- No Code Available32
- Pain27
- No Consequences Or Impact To Patient10
- Not Applicable10
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions8
- Unspecified Infection7
- Osteolysis6
P.F.C. SIGMA models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- P.F.C. SIGMA 86-4181PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER19 reports
- P.F.C. SIGMA 96-6683CLAMP18 reports
- P.F.C. SIGMA 86-4182PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- P.F.C. SIGMA 86-4177PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- P.F.C. SIGMA 86-4180PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- P.F.C. SIGMA 86-4183PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- P.F.C. SIGMA 98-6036Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing3 reports
- P.F.C. SIGMA 96-0131Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing2 reports
- P.F.C. SIGMA 1581-96-721PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- P.F.C. SIGMA 1581-96-750PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- P.F.C. SIGMA 1581-96-751PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- P.F.C. SIGMA 2-7581-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- P.F.C. SIGMA 86-4176PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- P.F.C. SIGMA 96-0132Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 report
- P.F.C. SIGMA 96-0761TEMPLATE1 report
- P.F.C. SIGMA 96-7508PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- P.F.C. SIGMA 98-6037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 report
- P.F.C. SIGMA 98-6038Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 report
Recent P.F.C. SIGMA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT PFC SIGMA STAB INS SZ3 8MM, PFC KEEL TIB TRAY CEM SZ3, PFC*SIGMA C/S NPOR FEM LT SZ 3, AND PFC*SIGMA/OV/DOME PAT 3PEG,38 WERE INVOLVED IN A REPORTED EVENT. THE PATIENT UNDERWENT PRIMARY TOTAL KNEE ARTHROPLASTY WITH THESE IMPLANTS, AND SUBSEQUENTLY REQUIRED REVISION SURGERY DUE TO LOOSENING AT THE TIBIA AND FEMUR. THE REVISION WAS COMPLETED SUCCESSFULLY USING PRODUCTS FROM ANOTHER COMPANY. ALL THREE COMPONENTS FEMORAL, TIBIAL TRAY, AND PATELLA WERE REVISED, WHILE THE TIBIAL INSERT WAS REPLACED TO ACCOMMODATE THE OTHER COMPONENTS.
Patient problems: Insufficient Information
MAUDE report 23863454 ↗MalfunctionDec 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA HEAD SLIDES OFF THE CLAMP BECAUSE THE JOINT HOLDING IT IN PLACE WAS WORN OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842793 ↗InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
(B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSE TIBIAL COMPONENT. PAIN WAS ALSO REPORTED. THERE WAS NO CEMENT LEFT ON THE TIBIAL COMPONENT. CEMENT MFG IS UNKNOWN.
Patient problems: Pain
MAUDE report 21986336 ↗MalfunctionOct 30, 2024Structural Problem; Structural Problem
IT WAS REPORTED THAT THE BUTTON DOES NOT STAY ON CLAMP. THE EVENT DID NOT HAPPEN DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570372 ↗InjuryApr 24, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: LOOSE (UNKNOWN COMPONENT OR INTERFACE) AND PAIN.
Patient problems: Pain
MAUDE report 19176100 ↗InjuryApr 23, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: LOOSE (UNKNOWN COMPONENTS OR INTERFACE). AT REVISION TIBIAL INSERT SHOWED MINOR YELLOWING AND SEVERAL POLY LOSS.
Patient problems: Insufficient Information
MAUDE report 19166005 ↗InjuryApr 16, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSE OF FEMUR AND PATELLA. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2002. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 19117443 ↗InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD A SIGMA TKA IMPLANTED AROUND THE YEAR 2000. ALL IMPLANTS WERE REMOVED AND REPLACED WITH ATTUNE REVISION. THE PATIENT COMPLAINED OF PAIN AND SURGEON FELT IT WAS TIME TO REMOVE THE OLDER KNEE AND REPLACE WITH AN ATTUNE. DOI- UNKNOWN DOR- (B)(6) 2024 AFFECTED SIDE- LEFT KNEE.
Patient problems: Pain
MAUDE report 18764279 ↗MalfunctionJun 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO SURGICAL DELAY AND THAT THE PATIENT DID NOT HAVE ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181472 ↗MalfunctionJun 22, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMP ATTACHMENT WON¿T STAY CONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181437 ↗InjuryMar 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
REVISION OF A PFC TKR DONE IN 2006. MALE, LEFT SIDE. ON THE JOINT REGISTRY FORM, THE REASON FOR REVISION WAS DUE TO DEEP INFECTION, TIBIAL LOOSENING, FEMUR LOOSENING. WHEN EXPOSURE WAS DONE THE SURGEON NOTED SIGNIFICANT POLY WEAR AS SEEN IN THE PICS. ALL COMPONENTS WERE REMOVED AND ATTUNE REVISION WAS IMPLANTED. THE PATIENT NOTES WERE UNAVAILABLE SO I WAS UNABLE TO GET THE LOT NUMBERS FROM THE IMPLANT STICKERS. THE ONLY LOT NUMBER I WAS ABLE TO READ ON THE IMPLANTS WAS FOR THE ONE STATED IN THE IMPACTED PRODUCTS. 86-4183 PFC KEELED TIBIAL TRAY SZ 5. THE TIBIA WAS VERY LOOSE. AS YOU CAN SEE IN THE PIC THERE IS CEMENT ON THE IMPLANT, SO BOTH INTERFACES FAILED. THE FEMUR FAILED AT THE BONE-CEMENT INTERFACE.
Patient problems: Unspecified Infection
MAUDE report 16501657 ↗MalfunctionJan 18, 2023Break; Break
THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16196205 ↗MalfunctionOct 10, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATELLA CLAMP HEAD (ORANGE RING) NO LONGER CLAMPS INTO THE PATELLA CLAMP. BOTH PIECES ARE BEING RETURNED. NO ADVERSE AFFECTS ON THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15568679 ↗InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OF LEFT PFC SIGMA CR FIXED BEARING KNEE FOR INSTABILITY. NO INFORMATION REGARDING PRIMARY SURGERY NO INFORMATION REGARDING HOSPITAL, SURGERY DATE OR SURGEON REGARDING PRIMARY SURGERY. NO INFORMATION IS AVAILABLE.
Patient problems: Joint Laxity; Pain
MAUDE report 15437842 ↗InjuryAug 29, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration
PRIMARY PFC FB OPERATION APPROX 15 YEARS AGO. TIBIA NEEDED REVISING. CR FEMUR REMAINS INSITU - TIBIA REMOVED AND MBT TRAY WITH SLEEVE AND STEM INSERTED DOI: JAN 2007. DOR: (B)(6) 2022. UNKNOWN SIDE.
Patient problems: Insufficient Information
MAUDE report 15312021 ↗
Other Depuy Orthopaedics, Inc. products
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- QUICKSET7 models · 3,790 reports
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- SUMMIT POROCOAT20 models · 1,646 reports
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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