P.F.C. SIGMA 96-0781Recalls & reported problems

Summary

The FDA's MAUDE database contains 236 adverse event reports that list this exact device (DI 10603295233916), received between Jun 23, 2017 and Aug 7, 2026 — classified as 225 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (36 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 236 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. Dartmouth 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 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 50179757 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED A SEVERE INFECTION. SO, ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC NAIL WAS PUT IN. DOI: (B)(6) 2019, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25681248 ↗
• 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 24982700 ↗
• 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 24957261 ↗
• InjuryApr 21, 2026Corroded

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2026. DARTHMOUTH 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 24941721 ↗
• 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 24825782 ↗
• MalfunctionJan 26, 2026Difficult to Advance

  IT WAS REPORTED THAT 5 DEGREE ADAPTOR DID NOT THREAD ALL THE WAY DOWN, WAS NOT USED. NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184033 ↗
• InjuryJan 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A FEMORAL REVISION PERFORMED DUE TO LOOSENING OF THE FEMORAL COMPARTMENT. LOOSING OCCURRED AT THE FEMORAL ADAPTER AND SLEEVE JUNCTION. THERE WAS NO SURGICAL DELAY. DOI: ON (B)(6) 2016, DOE: ON (B)(6) 2025, AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 24039719 ↗
• 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 23803027 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. THE EXAMINATION OF THE X-RAY SHOWS THAT THE FEMUR ADAPTER PIN IS BROKEN. CAN YOU PLEASE EXPLAIN THE REASON FOR THE REVISION? THE FEMORAL ADAPTER BOLT BETWEEN THE FEMORAL COMPONENT AND THE SLEEVE WAS BROKEN, THERE IS NO POSSIBILITY TO PLACE A NEW FEMORAL COMPONENT ON THE SLEEVE, THEREFORE A COMPLETE FEMORAL CHANGE INCLUDING THE SLEEVE + STEM WAS NECESSARY, THE TIBIAL COMPONENT APPEARED NATVIRADIOLOGICALLY AND ALSO INTRAOPERATIVELY SOLID. B. WAS THE BOLT BROKEN OR WAS THERE A FRACTURE OF THE FEMORAL BONE OR BOTH? THERE WERE BOTH. ULTIMATELY, IT WAS NO TRAUMA, THE PAT. A TRAUMATIC FEMORAL FRACTURE CANNOT HAVE BEEN THE CAUSE OF THIS. RATHER, THE FEMORAL FRACTURE WAS THE RESULT OF THE COUPLING FRACTURE WITH DISLOCATION OF THE FEMORAL COMPONENT. ANOTHER FACTOR THAT COULD HAVE PLAYED A PART WAS CERTAINLY THE OSTEOLYSIS OF THE DISTAL FEMUR IN STRESS SHIELDING BY THE WELL-FIXED FEMORAL SLEEVE, THEREBY THE DISTAL FEMUR AND THE BONY GUIDANCE WAS WEAKENED, AN INCREASED TRANSLATIONAL LOAD ON THE COUPLING MECHANISM COULD HAVE PLAYED A ROLE HERE. C. HAVE A FEMUR SLEEVE AND A FEMUR ADAPTER ALSO BEEN REVISED? UNFORTUNATELY, THERE IS NO WAY TO PUT A NEW FEMORAL TU

  Patient problems: Bone Notching; Limb Fracture

  MAUDE report 23717631 ↗
• 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: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23555757 ↗
• InjuryNov 13, 2025Naturally Worn; Naturally Worn

  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 23543362 ↗
• InjuryOct 15, 2025Fracture; Fracture

  PATIENT WAS REVISED DUE TO FEMORAL ADAPTOR WAS BROKEN. HAD TO REVISE FEMUR. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23294806 ↗
• 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 23016525 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 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: THE SIGMA FEMORAL COMPONENT, FEMORAL ADAPTOR AND TIBIAL INSERT WERE REVISED FOR INSTABILITY AND PAIN

  Patient problems: Joint Laxity; Pain

  MAUDE report 22668668 ↗
• 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 22646636 ↗
• InjuryJun 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT LEFT KNEE REVISION FAILED. ADAPTER BROKE. THE FEMUR WAS LOOSE AT CEMENT TO IMPLANT INTERFACE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2014. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22341266 ↗
• 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 21646586 ↗
• 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 21596985 ↗
• InjuryFeb 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE FEMORAL ADAPTOR BROKE, AND A NEW FEMUR, BOLT, ADAPTOR AND POLY WERE IMPLANTED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21402671 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS INSTABILITY. INTRAOPERATIVELY, IT WAS IDENTIFIED THAT THE TIBIAL BASE PLATE WAS LOOSE (INTERFACE NOT PROVIDED) AND HAD SUBSIDED. IT WAS ALSO NOTED THAT THE WELL-FIXED FEMUR WAS MALPOSITIONED/INTERNALLY ROTATED AND WAS EXPLANTED ALONG WITH THE TIBIAL TRAY AND INSERT. THE PATELLA COMPONENT WAS WELL-FIXED AND WAS RETAINED. REVISION TIBIAL TRAY AND REVISION FEMUR, WITH SLEEVE AND STEM FOR BOTH SIDE CONSTRUCTS WERE IMPLANTED, THERE WERE NO COMPLICATIONS REPORTED. NO PRODUCT INFORMATION WAS PROVIDED IN THE RECORDS FOR REVISED PRIMARY IMPLANTS OR RETAINED PATELLA. THE RECORDS DID PROVIDE A PARTIAL RECORD OF THE REVISION IMPLANTS PLACED DURING (B)(6) 2018 REVISION--THESE APPEAR TO BE ONLY FOR THE FEMUR SIDE OF THE KNEE (DEPUY FEMUR, AUGMENTS, SLEEVE, AND STEM, AS WELL AS DEPUY CEMENT). ON (B)(6) 2022, PATIENT'S LEFT KNEE WAS REVISED AGAIN TO ADDRESS SEVERE PAIN AND GROSS INSTABILITY. INTRAOPERATIVELY, THE WELL-FIXED FEMUR COMPONENTS WERE EXPLANTED FROM THE FEMORAL SLEEVE AND STEM, WHICH WERE WELL-FIXED AND RETAINED. AN S-ROM NOILES HINGED FEMUR WITH 2 FEMORAL AUGMENTS WAS IMPLANTED ALONG WITH 12MM THICK HINGED

  Patient problems: Joint Laxity; Pain

  MAUDE report 20659138 ↗
• 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: ON (B)(6) 2016. DOR: ON (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 20645512 ↗
• InjurySep 18, 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 20244622 ↗
• InjuryJun 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE LEFT KNEE WAS EXPLANTED DUE TO 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 19469707 ↗
• 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 19448636 ↗