SIGMA 96-0082Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295232490), received between Aug 30, 2017 and Apr 14, 2026 — classified as 39 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (13 reports).

8 other recalls cover devices cleared under the same FDA submission (K241000, K952830); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY OF TC3. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24876438 ↗
• InjuryJun 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  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 22341269 ↗
• InjuryFeb 4, 2025Loss of or Failure to Bond; Patient Device Interaction Problem; Loss of or Failure to Bond; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT HAD KNEE REPLACEMENT SURGERY ON AN UNKNOWN DATE. THE PATIENT HAS RECENTLY SEEN SURGEON FOR KNEE PAIN AND CLUNKING. SURGEON REVISED THE KNEE, WHICH WAS A TC3 FEMUR, INSERT, MBT SLEEVE, AND MBT TRAY CONSTRUCT. INTRAOPERATIVE SURGEON SAID THE CEMENTED SIZE 2.5 TC3 FEMUR WAS LOOSE AND EXPLANTED THE FEMUR, TC3 RP INSERT, AND LEFT THE PATELLA, MBT TRAY, AND MBT SLEEVE IN SITU. A NEW TC3 FEMORAL COMPONENT CONSTRUCT AND TC3 RP INSERT WAS IMPLANTED. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21306113 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC PAIN. PATIENT SEEN IN ED WITH DISLOCATED KNEE. CORRECTIVE SURGERY HAD MASSIVE METALLOSIS, OSTEOLYSIS, AND POLYETHYLENE WEAR. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 20280805 ↗
• InjuryApr 10, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  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 19081125 ↗
• InjuryMar 15, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE BOLT INTERFACE. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18912125 ↗
• 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 18785451 ↗
• 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 18654935 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION DUE TO PAIN. PATIENT'S FEMORAL COMPONENT WAS FOUND TO BE SLIGHTLY LOOSE SO IT WAS REMOVED AND REPLACED WITH ANOTHER FEMORAL COMPONENT OF THE SAME SIZE. THE LOOSENING INTERFACE WAS AT THE BONE TO CEMENT. CEMENT MANUFACTURER IS UNKNOWN. THE POLY INSERT WAS ALSO REPLACED. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18074890 ↗
• InjurySep 20, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS IDENTIFIED THAT ON (B)(6) 2023, THERE WAS A REPORT FOR ASEPTIC LOOSENING LEFT REVISION (KNEE HAS BEEN REVISED IN THE PAST). DOI: (B)(6) 2013. DOR: UNKNOWN. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17781240 ↗
• InjuryMay 12, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT COMES FOR FURTHER DISCUSSION REGARDING PAINFUL BILATERAL TOTAL KNEE ARTHROPLASTIES. THE PATIENT HAD A RIGHT TOTAL KNEE IN 2006 AND REVISION IN 2019. SHE HAD A LEFT TOTAL KNEE IN 2006, A REVISION IN 2019 AND A SCOPE DEBRIDEMENT IN 2020. THE PATIENT CONTINUES TO HAVE ONGOING PAIN AND DISCOMFORT IN BOTH OF THE KNEES. THE PAIN IS DAILY. IT IS STARTING TO LIMIT HER ACTIVITIES. SHE HAS GOOD RANGE OF MOTION. SHE HAS SOME SWELLING AT TIMES. SHE HAS SOME GRINDING AND POPPING IN BOTH KNEES. THE LEFT KNEE HURTS MORE OFTEN THAN THE RIGHT KNEE. SHE DID PREVIOUSLY DISCUSS REVISION SURGERY WITH SURGEON. SHE WOULD LIKE TO PROCEED WITH STAGED TKA REVISIONS, LEFT ONE FIRST. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

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

  MAUDE report 16918622 ↗
• InjuryMay 3, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  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 16860376 ↗
• 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; Limb Fracture; Pain

  MAUDE report 16706331 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISTAL FEMORAL FRACTURE OF LEFT KNEE ABOVE IMPLANT. DISTAL FEMORAL REPLACEMENT LPS SYSTEM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 15391894 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNEE INFECTION. ALL COMPONENTS REMOVED AND ANTIBIOTIC CEMENT SPACERS WERE IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. BONE CEMENT WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14213382 ↗
• 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. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14141802 ↗
• InjuryApr 18, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO THE FEMORAL COMPONENT BEING LOOSE AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Insufficient Information

  MAUDE report 14138768 ↗
• InjuryFeb 10, 2022Fracture; Fracture

  CLINICAL NOTIFICATION RECEIVED FOR REVISION FEMORAL COMPONENT IMPLANT FRACTURE. DATE OF IMPLANTATION: (B)(6) 2008, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: REVISION OF THE FEMORAL COMPONENTS AND TIBIAL INSERT.

  Patient problems: Insufficient Information

  MAUDE report 13505512 ↗
• InjuryAug 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF TOTAL LEFT KNEE REPLACEMENT ON SEPSIS AND LOOSENING. FRACTURE / LOOSENING OF THE FEMORAL BOLT SCREW. CONSEQUENCE ON THE PATIENT: PAIN +++, NO DEBRIS, DISPLACEMENT OF THE FEMUR. DOI: (B)(6) 2019; DOR: UNKNOWN; LEFT KNEE.

  Patient problems: Joint Dislocation; Pain; Sepsis

  MAUDE report 12357965 ↗
• InjuryJul 20, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL AND FEMORAL COMPONENT AT THE BONE TO CEMENT & CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. TIBIAL COMPONENT LOOKED LOOSE ON X-RAY. DURING PROCEDURE FEMORAL IMPLANTS WERE LOOSE AS WELL. RIPPED OUT ALL COMPONENTS WITH THE EXCEPTION OF 35 ROUND PATELLA. DOI: (B)(6) 2014 DOR: (B)(6) 2021 LEFT KNEE

  Patient problems: Insufficient Information

  MAUDE report 12196044 ↗
• MalfunctionJun 16, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2021, THE PATIENT PRESENTED FOR A LEFT KNEE EVALUATION DUE TO PATELLA CLUNK. THE PHYSICIAN INDICATED THE LEFT KNEE DEVELOPED A LOT OF SCAR TISSUE AND SOME LAXITY. THE PHYSICIAN INDICATED IF THE PATIENT'S SYMPTOMS WORSEN HE WOULD BE A CANDIDATE FOR AN ARTHROSCOPIC DEBRIDEMENT. THERE IS NO EVIDENCE OF REVISION, INVASIVE INTERVENTION, OR TREATMENT.

  Patient problems: Adhesion(s); Insufficient Information; Joint Laxity

  MAUDE report 12010444 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT RECEIVED A SECOND LEFT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, REMOVAL OF FIBROUS TISSUE, AND PATELLAR TENDON REPAIR. ALL PRODUCTS WERE REVISED WITH THE EXCEPTION OF THE PATELLAR COMPONENT, WHICH WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR FEMORAL COMPONENT AND UNIVERSAL SLEEVE, DEPUY TIBIAL TRAY, STEM, AND INSERT, AND DEPUY CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017 (PATELLA), DOI: (B)(6) 2018 (COMPETITOR CEMENT, INSERT, TIBIA AND FEMUR - CAPTURED IN (B)(4)), DOR2: (B)(6) 2019, LEFT KNEE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain

  MAUDE report 12010174 ↗
• InjuryMay 25, 2021Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE UNKNOWN INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11880850 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A DISLOCATED TC3 RP REVISION KNEE. PATIENT'S SOFT-TISSUE WAS DISCOVERED TO BE COMPROMISED UPON EXPOSURE OF THE JOINT. THE PATIENT WAS REVISED TO AN SROM HINGE WITHOUT ISSUE. THE INSERT WAS STILL IN THE TRAY AND DID NOT SPIN 90 DEGREES. THE FEMUR DISLOCATED DUE TO SOFT TISSUE INJURY.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 11495121 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGERY DELAY WAS APPROXIMATELY 2 HOURS.

  Patient problems: No Code Available; Pain

  MAUDE report 9707419 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K952830. One submission often covers many models, so check the product and lot details in each record.

• Z-2949-2018 · Jul 18, 2018 · Terminated
  P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
• Z-0400-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544.
• Z-0398-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0523.
• Z-0401-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551.
• Z-0397-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522.
• Z-0396-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521.
• Z-0399-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.
• Z-1369-04 · Dec 22, 2003 · Terminated
  P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703