P.F.C. SIGMA 96-0783Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10603295233930), received between Nov 4, 2017 and Aug 7, 2026 — classified as 80 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (23 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Loss of or Failure to Bond

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to unspecified loosening and instability. The non-articular surface of the cemented CC femoral component shows moderate cement remaining.The non-articular surface of the cemented tibial tray shows abundant cement remaining

  Patient problems: Joint Laxity

  MAUDE report 50179181 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE BECAUSE OF A BROKEN CONDYLE. CEMENT MANUFACTURER WAS UNKNOWN. IMPLANT WAS PUT IN ON (B)(6) 2019. THE PATIENT WAS COMPLAINING OF PAIN AND THE BONE SCAN SHOWED LOOSENING OF THE FEMORAL IMPLANT. WHEN THEY GOT IN THERE, THE IMPLANT WAS LOOSE BECAUSE THERE WAS A FRACTURE OF THE LATERAL FEMORAL CONDYLE AFTER SEVERAL FALLS. NO INFECTION WAS PRESENT SO THEY WENT TO A PROM HINGE . DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 24957469 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNIVERSAL FEM SLV DIS POR 31MM, SIGMA FEM ADAPTER NEUTRAL BOLT, AND AN UNKNOWN KNEE FEMORAL ADAPTOR WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A TC3 DEPUY PROSTHESIS WHERE, DURING A POST-OPERATIVE PERIOD, ABUNDANT METALLOSIS WAS OBSERVED IN THE KNEE WITHOUT NOTICEABLE WEAR OF THE POLYETHYLENE. UPON EXTRACTION, ABNORMAL ROTATIONAL MOVEMENT WAS DETECTED BETWEEN THE FEMORAL SHIELD AND THE METAPHYSEAL SLEEVE, WHICH ARE TYPICALLY JOINED BY AN IMPACTED MORSE CONE SYSTEM. THIS MOVEMENT WAS IDENTIFIED AS THE SOURCE OF METAL DEBRIS. THE FEMORAL COMPONENT REMAINED HELD BY THE KEEL IN THE FEMORAL DIAPHYSIS, BUT THE EPIPHYSEAL PART OF THE IMPLANT EXHIBITED ROTATIONAL MOBILITY RELATIVE TO THE FEMUR. THE NEUTRAL BOLT AND ASSOCIATED PARTS APPEARED VISUALLY SEALED. THE PROSTHESIS WAS CHANGED.

  Patient problems: Foreign Body Reaction

  MAUDE report 23728399 ↗
• InjuryFeb 10, 2025Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT SIDE AND THE ADAPTER BOLT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345775 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO LOOSENING. THE CEMENT MANUFACTURER WAS COMPETITOR. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20223158 ↗
• InjuryJun 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE LEFT KNEE WAS EXPLANTED DUE TO FAILURE/BREAKAGE OF FEMORAL. FEMORAL ADAPTER/BOLT. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : LEFT KNEE

  Patient problems: Discomfort; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 19509019 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE CONFIRM WHAT IMPLANTS WERE MISPOSITIONED. ¿ FEMORAL COMPONENT AND TIBIAL TRAY. B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, DUE TO THE MISPOSITIONING OF THE IMPLANTS. C. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. D. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, ALL CORRECT SIZING. E. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, REPORTED AS OKAY. F. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Joint Laxity

  MAUDE report 19261602 ↗
• InjuryApr 30, 2024Fracture; Fracture

  PATIENT WAS REVISED DUE TO BROKEN ADAPTOR/BOLT IN REVISION TKA CONSTRUCT. DOI: (B)(6) 2015. DOR: (B)(6) 2024. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19216308 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A FIRST STAGE REVISION FOR INFECTION. TC3 IMPLANTS INSITU WHICH WERE REMOVED AND A CEMENT SPACER REPLACED. REVISION WILL BE BOOKED ONCE INFECTION CLEARS. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18785445 ↗
• InjuryFeb 14, 2024Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO B. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO C. IS/ARE THE PRODUCT/S AVAILABLE FOR RETURN? YES OR NO? YES D. WAS THERE ANY REVISION SURGERY THAT OCCURRED? IF YES, PLEASE PROVIDE THE DETAILS. YES, S-ROM HINGE KNEE WITH SLEEVE & STEM FEMORAL AND TIBIAL WITH SLEEVE AND STEM E. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT F. PLEASE CLARIFY THE CORRECT DEFECTIVE DEVICE(S) AS THE EVENT DESCRIPTION INDICATES STEM, BUT A SLEEVE WAS REPORTED. KINDLY EXPLAIN THE SPECIFIC DEFECT OF THE DEVICES. THE THREAD OF THE +/- BOLT HAS BROKEN, PLEASE SEE THE IMPLANTS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705777 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18655375 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNDISCOVERED NICKEL ALLERGY. THEY HAD PAIN THROUGHOUT THEIR LEG, SO THE SURGEON REPLACED EVERYTHING WITH COMPETITOR IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18184814 ↗
• InjuryJul 12, 2023Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THE FOLLOWING: THE FEMUR WAS CONFIRMED TO BE LOOSE. THERE WAS NO DAMAGE ON THE SLEEVE, IT WAS WELL FIXED IN THE BONE. THERE WERE NO PATIENT ADVERSE CONSEQUENCES REPORTED. DOR: (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17313392 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF RIGHT KNEE. ALL IMPLANTS WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16862191 ↗
• InjuryMay 3, 2023Fracture; Fracture

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT. ADAPTER BOLT WAS BROKEN AT THREADS. ALL PARTS WERE REMOVED. SLEEVE AND STEM WERE WELL FIXED AND WERE NOT REMOVED. S ROM HINGE FEMUR WAS IMPLANTED. TIBIAL COMPONENT WAS NOT REVISED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16860381 ↗
• InjuryApr 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE TC3 TOTAL KNEE PROSTHESIS HAS BEEN "UNBUNDLED." IT WAS DECIDED TO POSE A NOILES, TAKING INTO ACCOUNT THE NUMBER OF INTERVENTIONS ALREADY UNDERWENT BY THE PATIENT WITHOUT CHANGING THE TIBIA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 16706330 ↗
• InjuryApr 5, 2023Fracture; Fracture

  REVISION COMPLETED DUE TO KNEE PAIN AND INSTABILITY. UPON TAKING AN X-RAY, IT WAS SHOWN THAT THE NEUTRAL ADAPTER BOLT HAD BROKEN OFF AND WAS FLOATING IN THE PATIENTS KNEE. THIS MEANT THE FEMORAL COMPONENT HAD COME DISENGAGED FROM THE CEMENTED SLEEVE AND STEM CONSTRUCT. UPON OPENING THE KNEE, THE BROKEN BOLT AND FEMUR WERE TAKEN OUT EASILY. THE 5 DEGREE FEMORAL ADAPTER WAS STILL TAPER ENGAGED IN THE 20MM CEMENTED SLEEVE. THERE WAS LOOSENING REPORTED AT THE BONE/CEMENT INTERFACE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16683075 ↗
• InjuryFeb 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON TUESDAY, (B)(6) 2023 AT BRYN MAWR HOSPITAL IN BRYN MAWR, PA, DR. ELECTED TO REVISE THE LEFT KNEE OF A PATIENT WHO HAD THE SAME KNEE REVISED AT YORK HOSPITAL IN YORK, PA ON (B)(6) 2019. PATIENT HAD PRESENTED IN CLINIC WITH A PAINFUL AND EFFUSED LEFT KNEE. UPON EXPOSURE TO THE JOINT SPACE, DR. DEBRIDED BLACKENED TISSUE FROM THE JOINT SPACE. UPON FLEXING THE KNEE DR. REMOVED THE TC3 RP POLY WITH A PAIR OF RONGEURS. DR. THEN REMOVED THE FEMORAL COMPONENT WITH A TAMP AS WELL AS A FEMORAL GRIPPER AND SLAP HAMMER. UPON EXPLANTING THE FEMORAL COMPONENT A FEMORAL AUGMENT FELL OFF THE CONSTRUCT BUT IT WAS NOT BROKEN IN ANY MANNER. THE 46 FEMORAL STEM WAS WELL FIXED TO THE ADAPTER BUT THE ADAPTER ITSELF WAS LOOSE ON THE BACK OF THE SZ4 LEFT TC3 FEMORAL COMPONENT. DR. WAS ABLE TO UNSCREW THE FEMORAL STEM FROM THE ADAPTER WITH HIS HANDS. CEMENT HAD ENCAPSULATED THE ENTIRE BACK OF THE FEMUR, SLEEVE, ADAPTER AND PART OF THE FEMORAL STEM. DR. ALSO FOUND SUTURES IN THE MEDIAL CONDYLE REGION OF THE FEMUR SUGGESTING A MCL REPAIR. DR. TESTED THE TIBIA AND WAS SATISFIED THAT IT WAS WELL FIXED AND ELECTED TO LEAVE THE CONSTRUCT IMPLANTED. AFTER REMOVING ALL THE CEMENT FROM THE FEMUR, DR. PREPPED THE

  Patient problems: Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16311270 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6). AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16246211 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TC3 REVISION KNEE? INFECTED - UNSTABLE SIGNASURE CAME BACK NEGATIVE FOR INFECTION PREVIOUS IV DRUG ABUSER, HIGH FUNCTIONING KNEE PLAN A- ATTUNE REVISION, PLAN B - ATTUNE HINGE PLAN C - TC3 FEMUR REVISION IF TIBIA WELL FIXED IN SITU - TC3FEMUR SIZE 4 PLUS DISTAL AND POSTERIOR AUGMENTS, STEM AND ADAPTOR MBT TIBIA REVISION SIZE 3, WEDGE, STEM SIZE 4 20MM INSERT TC3 RP PATELLA 41MM 3 PEG.

  Patient problems: Joint Laxity

  MAUDE report 16017394 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION TKR AS PART OF A SECOND STAGE DUE TO INFECTION. PATIENT HAS PRESENTED TO DR DAVID LIU AND UNDERGONE A POLY EXCHANGE AND WASHOUT. AT THIS STAGE, ON OPENING THE KNEE, THE KNEE WAS OBVIOUSLY PUSSY AND INFECTED. THE KNEE WAS WASHED OUT AND THE POLY BEARING EXCHANGED. SAMPLES TAKEN AT THIS STAGE ARE POSITIVE FOR BACTERIA (SENSITIVE STRAIN). A DECISION WAS MADE TO GO BACK INTO THE KNEE AND REMOVE ALL COMPONENTS AS PART OF A TWO STAGE PROCEDURE. ON OPENING THE KNEE IT APPEARED RELATIVELY ANGRY BUT NOT OVERTLY PUSSY. THE COMPONENTS WERE REMOVED, THE TISSUE DEBRIDED AND A TEMPORARY "KIWI" SPACER IMPLANTED (ATTUNE PS FEMUR AND AN ATTUNE PS RP INSERT) AS PART OF THE TEMPORARY SPACER. THESE WILL BE REMOVED IN DUE COURSE AND EXCHANGED FOR A REVISION SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 15973957 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INFECTION ON RIGHT KNEE. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15926463 ↗
• InjuryOct 28, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IMPLANT DISPOSED OF LOCALLY. NO ADDED TIME IN THEATRE. THIS REVISION APPEARED TO BE AN OPERATIONAL SUCCESS.

  Patient problems: Insufficient Information

  MAUDE report 15691484 ↗
• MalfunctionAug 24, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE ADAPTER IS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281952 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT RESECTION WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14142060 ↗