P.F.C. SIGMA 96-0784Recalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 10603295233947), received between Jun 23, 2017 and Aug 7, 2026 — classified as 161 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (49 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 164 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50173024 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEPTIC A LOOSENING. IT WAS STATED THAT FEMUR/TIBIA WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24981997 ↗
• InjuryApr 21, 2026Degraded; Fracture; Naturally Worn

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2026. (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: LOOSE FEMUR/ BROKEN BOLT/POLY WEAR/PAIN. RETRIEVAL ANALYSIS IDENTIFIED THE FEMORAL COMPONENT, STEM, AND AUGMENT WERE LOOSE AT THE UNKNOWN CEMENT TO IMPLANT INTERFACE. THERE WAS CORROSION AND AROUND THE STEM/BOLT JUNCTION. THE BOLT WAS WORN AND FRACTURED. THERE WAS ALSO METAL WEAR ON THE ARTICULAR SURFACE OF THE FEMORAL COMPONENT AND WEAR OF THE POLY LINER.

  Patient problems: Pain

  MAUDE report 24941723 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24825780 ↗
• InjuryMar 16, 2026Fracture

  ADDITIONAL INFORMATION RECEIVED: UPDATED: MEDICAL RECORD AD (B)(6) 2026 HAVE BEEN REVIEW BY A CLINICIAN: ON (B)(6) 2016: MALE PATIENT RECEIVED A RIGHT KNEE REVISION OF AN UNK TKA TO TREAT STIFFNESS, ARTHROFIBROSIS, AND PAIN. THE PATIENT RECEIVED A DEPUY TC3 INCLUDING A FEMORAL SLEEVE, FEMORAL ADAPTOR AND BOLT, HINGED FEMORAL COMPONENT, HINGED TIBIAL INSERT, MBT TIBIAL TRAY, TIBIAL SLEEVE, AND TIBIAL STEM. THE UNKNOWN PATELLA WAS RETAINED. UNK CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2016 THE MALE PATIENT RECEIVED AN MUA, SYNOVASURE ASPIRATION, AND INTRAARTICULAR INJECTION TO TREAT PAIN, SWELLING, STIFFNESS, AND ARTHROFIBROSIS S/P TC3 IMPLANTATION. NO INFECTION WAS DETECTED AND ROM RESTORED TO NORMAL LIMITS. THIS IS A NEW EVENT TO BE CAPTURED ON A LINKED, SEPARATE COMPLAINT. DOI: (B)(6) 2016, DOE:(B)(6) 2016, RIGHT KNEE.

  Patient problems: Adhesion(s); Calcium Deposits/Calcification; Joint Laxity; Muscular Rigidity; Pain

  MAUDE report 24605138 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED WITH TC3 FEMUR WITH POROUS COATED SLEEVE DUE TO INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23803025 ↗
• InjuryDec 4, 2025Fracture; Fracture

  IT WAS REPORTED THERE WAS A FRACTURE IN THE LEFT KNEE. A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2025. IT WAS NOTED THE BONE BEHIND THE FEMORAL COMPONENT WAS IN A VERY BAD CONDITION, THERE WAS NO BONY SUPPORT FOR THE METAL COMPONENT.

  Patient problems: Bone Notching; Limb Fracture

  MAUDE report 23717611 ↗
• InjuryNov 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TC3 BOLT CAME LOOSE FROM ADAPTER AND FEMUR WAS MOVING IN THE JOINT. SLEEVE REMAINED AND PATIENT WAS REVISED TO A NOILES FEMUR/POLY HINGE KNEE WAS IMPLANTED. THERE WAS LOOSENING OF FEMUR, BOLT, ADAPTER AT NON-CEMENTED INTERFACE. CEMENT MANUFACTURE WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23555751 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD DEVELOPED PAINFUL LAXITY OVER TIME. THE COMPONENTS APPEARED TO BE WELL FIXED. A REVISION KNEE WAS SCHEDULED TO ADDRESS LAXITY. DURING THE OPERATION, IT WAS NOTED THAT THERE WAS METAL DEBRIS BEING GENERATED BY THE PROSTHESIS AS THERE WAS STAINING THROUGHOUT THE CAPSULE. THE FEMORAL COMPONENT WAS REMOVED, AND IT APPEARED THAT THE DEBRIS WAS BEING GENERATED AT THE TAPER BETWEEN THE FEMORAL ADAPTER AND THE FEMORAL SLEEVE; BOTH OF WHICH WERE WELL FIXED. THE WELL-FIXED TIBIAL TRAY WAS REMOVED. TRIALS WERE PLACED AND MOTION AND STABILITY WAS CONFIRMED. FINAL COMPONENTS WERE PLACED. NO PATIENT HARM NOR DELAY WAS NOTED. PATIENT APPEARED HAVE HAD THICKER INSERTS PLACED ON (B)(6) 2020 AND (B)(6) 2021. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23543380 ↗
• InjuryNov 4, 2025Degraded; Degraded

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH 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 ARTHROFIBROSIS. FEMORAL COMPONENT HAD MINOR CORROSION.

  Patient problems: Adhesion(s); Arthrofibrosis

  MAUDE report 23465446 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO INFECTION. ALL PARTS WERE EXPLANTED AND A CEMENT SPACER FROM A DIFFERENT VENDOR WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23016519 ↗
• InjuryJul 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TC3 ADAPTER AND THE BOLT BROKE IN THE PATIENT. THE DISTAL ENDS OF THE ADAPTOR AND BOLT BROKE OFF AND THE PROXIMAL PORTIONS OF THE ADAPTOR AND BOLT WERE STUCK INSIDE THE SLEEVE AFTER FEMUR WAS REMOVED. NO INFORMATION ON WHERE THE PATIENT FELL OR NOT BUT THOSE IMPLANTS WERE FOUND BROKE WHEN INCISION WAS MADE AND ON PRE-OP X-RAY. TIBIAL IMPLANTS WERE RETAINED. DOI: (B)(6) 2018, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 22647034 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF LEFT KNEE DUE TO INSTABILITY. TC3/MBT IN SITU, TC3 REMOVED AND S-ROM HINGE IMPLANTED. TC3 POLY WAS WORN AND POLY SPINE FRACTURED. SIZE 5 LEFT TC3 FEMORAL COMPONENT. NO ALLEGATIONS AGAINST THE TIBIAL TRAY.

  Patient problems: Joint Laxity

  MAUDE report 22580717 ↗
• InjuryMar 19, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT STATES HE HAD KNEE REPLACEMENT AROUND 2004, HAD REVISION DONE IN 2016 IN (B)(6) BY SURGEON AT A HOSPITAL. HE CONTINUED TO HAVE ISSUES AND IN (B)(6) 2023, HE WENT TO ANOTHER SURGEON IN ANOTHER HOSPITAL WHO REPLACED WHAT HE CONSIDERED DAMAGED COMPONENTS.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21646584 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL RIGHT KNEE. SURGEON CONVERTED FROM A TC3 TO DISTAL FEMORAL REPLACEMENT. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21596887 ↗
• InjuryFeb 5, 2025Fracture; Fracture

  IT WAS REPORTED A LEFT KNEE REVISION FOR FAILED REVISION ARTHROPLASTY. ADAPTER BOLT AND ADAPTER BROKEN. ADAPTER WAS NOT ABLE TO BE REMOVED FROM UNIVERSAL SLEEVE. THE SURGEON TRIED FOR 90 MINUTES TO REMOVE THE ADAPTER FROM THE SLEEVE BUT WAS UNSUCCESSFUL. THE SURGEON DECIDED TO TRANSFER THE PATIENT TO ANOTHER FACILITY FOR TREATMENT AND MOST LIKELY A DISTAL FEMORAL REPLACEMENT. PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND HAD TO BE ABORTED AND PATIENT TRANSFERRED.

  Patient problems: Insufficient Information

  MAUDE report 21314940 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LOSS OF MOBILITY DUE TO SUSPECTED HETEROTOPIC OSSIFICATION. THE PATIENT HAD A DEPUY TC3 RP REVISION KNEE. THE SZ 4 TC3 RIGHT FEMUR, 5 DEGREE BOLT, +2/-2 FEMORAL ADAPTOR, TC3 SZ 4 X 4 DISTAL AUGMENTS X2, TC3 SZ 4 X 4 POSTERIOR AUGMENT, 115 X 16 STEM AND TC3 RP SZ 4 X 12.5 INSERT WERE EXPLANTED. DOI: (B)(6) 2016, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 20646247 ↗
• InjurySep 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE BOLT BROKE OFF ADAPTER AND WAS FLOATING IN THE JOINT, HAD TO DO A DFR. DOE: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20301629 ↗
• InjuryJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED WITH THE FEMUR BECAUSE OF LOOSENING BETWEEN THE ADAPTER AND OFFSET BOLT. LOOSENING INTERFACE UNKNOWN. SURGICAL DELAY UNKNOWN. DOI; UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448634 ↗
• InjuryApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO FEMORAL ADAPTER BOLT FAILURE AND LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE. DOI: (B)(6) 2010. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19081129 ↗
• InjuryMar 15, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY?: NO. B. PLEASE CLARIFY THE LOOSENING COMPONENT/S. FEMUR AND BOLT. C. PLEASE PROVIDE THE LOOSENING INTERFACE. FEMUR/BOLT. D. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS AND QUANTITY OF THE CEMENT. NO INFORMATION FOR WHICH CEMENT WAS USED. E. WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE DEFICIENCY WITH THE SIGMA FEM ADAPTER 5 DEGREE AND SIG FEM ADAP +2/-2 OFFSET BOLT. IF YES, PLEASE PROVIDE DETAILS. SURGEON JUST SAID HE THOUGHT IT BROKE. F. PLEASE CONFIRM IF THE BOLT DISASSOCIATED FROM THE ADAPTER. BOLT DID NOT DISASSOCIATE FROM ADAPTER.

  Patient problems: Insufficient Information

  MAUDE report 18912065 ↗
• InjuryMar 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE FEMUR WAS LOOSE DUE TO BROKEN ADAPTER BOLT. DOI: (B)(6) 2018. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18885622 ↗
• InjuryFeb 16, 2024Fracture; Fracture

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE OFFSET FEMORAL ADAPTER BOLT BROKE OFF INSIDE 5 DEGREE FEMORAL ADAPTER, CAUSING THE SIZE 4 TC3 FEMUR TO BECOME LOOSE. THERE WAS SURGICAL DELAY OF 2.5 HOURS. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18721062 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO NICKEL ALLERGY. DOI: UNKNOWN. DOR: (B)(6), 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18570768 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SALES REP IS REPORTING A FRACTURE OF THE FEMORAL TAPER COMPONENT.

  Patient problems: Joint Laxity

  MAUDE report 18484714 ↗