SIGMA 96-0090Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10603295232575), received between Jun 26, 2017 and Mar 16, 2026 — classified as 43 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Loss of or Failure to Bond

  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 24605121 ↗
• 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 23803028 ↗
• 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 23016530 ↗
• 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 20223151 ↗
• InjuryJun 3, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  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 19448637 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CHRONIC EFFUSION, DECREASED ROM, AND INCREASED PAIN. FEMORAL REVISION AND POLY EXCHANGE PERFORMED. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

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

  MAUDE report 17928215 ↗
• InjuryJun 2, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO PROGRESSIVE RIGHT KNEE PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN, DOI- (B)(6) 2016. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17049727 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FEMORAL REVISION ONLY AND CONVERSION TO A HINGED FEMORAL PROSTHESIS DUE TO MEDIAL COLLATERAL INSTABILITY. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15996108 ↗
• InjuryNov 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LUXATION IN A KNEE REPLACEMENT. PRODUCT: TOTAL KNEE PROTESIS. LOT: UNKNOWN. DIAGNOSIS: GONARTHROSIS (KNEE ARTHROSIS).

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 15870775 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO UNKNOWN REASONS. PATIENT WAS REVISED TO A HINGE. NOTHING FURTHER TO REPORT. THE CEMENT MANUFACTURER WAS NOT INDICATED. NO LOOSENING EXPERIENCED. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15336412 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS INFECTION, PAIN, SWELLING, SYNOVITIS, REMOVAL OF FIBROUS TISSUE, AND TIBIAL COMPONENT LOOSENING. THE SURGEON HAD TO PERFORM A CORONAL PLANE OSTEOTOMY OF THE DISTAL FEMUR TO REMOVE THE WELL-FIXED FEMORAL COMPONENTS. THERE WAS NOTED TO BE REMOVAL OF CERCLAGE WIRES ON THE FEMUR THAT WERE PLACED PRIOR FOR AN UNKNOWN REASON ON AN UNKNOWN DATE. IT IS UNKNOWN IF THE WIRES WERE PREVIOUSLY PLACED DUE TO A COMPLICATION OR TO PREVENT ANY ISSUES.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 12862930 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISE DUE TO INFECTION AND LOOSENING OF THE FEMUR AND TIBIA COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. ALL COMPONENTS ARE BEING REMOVED AND A CEMENT SPACER IS BEING IMPLANTED. PATIENT FIRST REIMPLANTATION USING DEPUY PRODUCTS WAS ON (B)(6) 2020. INCLUDED THE PARTS FROM WHICH NUMBERS COULD BE OBTAINED. THE KNEE HAS AUGMENTS, STEMS AND SLEEVES FROM WHICH NUMBERS COULD NOT BE OBTAINED. PATIENT HAD A POLY EXCHANGE ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020 (FEMUR, TIBIA, AUGMENTS, SLEEVE & STEM), (B)(6) 2021 (TIBIAL INSERT), DOR: (B)(6) 2021 ; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12632491 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED LAST (B)(6) 2021 DUE TO STAGE 1 INFECTION. SURGERY WAS DONE AT (B)(6) HOSPITAL. THE 1ST REVISION WAS DONE ON (B)(6) 2016. DOI: (B)(6) 2016. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12542233 ↗
• MalfunctionJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS HAD A TC3 DEPUY REVISION KNEE COMPONENT INSITU SINCE 2013, THE PATIENT PRESENTED WITH PAIN, HEARD A CRACK IN HIS KNEE WHEN GETTING OFF A STATIONARY BIKE. UPON XRAY, IT REVEALED HE BOLT HAD BROKEN IN THE FEMORAL COMPONENT OF THE TC3 AND THE ADAPTER.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12066841 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OFFICE NOTES ''(B)(6) 201'' - (B)(6) 2019 INDICATE THE PATIENT IS EXPERIENCING SWELLING, POPPING, INSTABILITY AND PAIN OF THE LEFT KNEE. HE IS ALSO EXPERIENCING SWELLING, PAIN, NUMBNESS AND INSTABILITY IN THE RIGHT KNEE AND FEELINGS OF CRUNCHING AND CRACKING. CURRENT TREATMENT INCLUDES ORAL PAIN MEDICATION, PHYSICAL THERAPY, KNEE BRACES AND NERVE BLOCKS. NO EVIDENCE OF ADDITIONAL REVISION OF PRODUCTS. DOI: ''(B)(6) 201'' (TRAY - CAPTURED IN (B)(4)). DOI: (B)(6) 2019 (FEMUR, PATELLA AND INSERT - CAPTURED IN (B)(4)). DOR: NONE REPORTED; RIGHT KNEE.

  Patient problems: Joint Laxity; Numbness; Pain; Swelling/ Edema

  MAUDE report 11728247 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PERIPROSTHETIC KNEE INFECTION. NO DELAY IN SURGERY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11398436 ↗
• InjuryJan 12, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PATIENT'S KNEE WAS REVISED DUE TO HUGENESS AND AN LPS INSERT WAS USED TO GAIN STABILITY. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNK, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11155625 ↗
• InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 09 OCT 2018, IT WAS REPORTED THAT THE SURGEON REPORTED A SMALL CRACK IN THE DISTAL FEMUR WHEN PLACING THE METAPHYSEAL SLEEVE AND A SMALL CRACK IN THE PROXIMAL TIBIA AS WELL WHEN PLACING THE DEFINITIVE COMPONENTS WITH A METAPHYSEAL SLEEVE. CABLES WERE PLACED. DEPUY COMPONENTS WERE PLACED DURING THIS PROCEDURE INCLUDING DEPUY CEMENT WITH GENTAMICIN.

  Patient problems: Bone Fracture(s)

  MAUDE report 10993595 ↗
• InjuryDec 10, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2019 IT WAS REPORTED THAT THE PATIENT HAD AN ARTHROSCOPIC DEBRIDEMENT OF RIGHT QUADRICEPS SCAR TISSUE NODULE TO ADDRESS PATELLAR CLUNK OF THE RIGHT KNEE.

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

  MAUDE report 10988078 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 10986364 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10810416 ↗
• InjuryOct 9, 2020Off-Label Use; Off-Label Use

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR BOLT AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A 2 STAGE BILATERAL KNEE REPLACEMENT REVISION SURGERY APPROXIMATELY 5 YEARS AGO AT THE HSS IN NEW YORK. PATIENT WAS ALLERGIC TO BONE CEMENT SO THE REVISION WAS DONE WITH SIGMA FEMORAL SLEEVES AND TC3 FEMURS WITH A MBT REVISION TIBIA WITH SLEEVES ON BOTH THE RIGHT AND LEFT WITHOUT USING CEMENT. FEMUR ON RIGHT SIDE WAS UNSUPPORTED BY BONE AND HAD DEVELOPED METAL DEBRIS FROM THE ZERO BOLT AND SLEEVE ADAPTER. SURGEON REMOVED FEMUR AND REPLACED WITH A DISTAL FEMUR ON THE RIGHT SIDE. SLEEVES ON BOTH SIDES WERE WELL FIXED ON THE RIGHT SIDE. DOI: (B)(6) 2015, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10656222 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR WHERE A STRYKER KNEE WAS UTILIZED. THIS KNEE WAS LATER REVISED TO A STRYKER REVISION. ON THE (B)(6) 2015 THE STRYKER REVISION KNEE WAS REVISED TO A PFC TC3. PATIENT HAS PRESENTED WITH A PAINFUL AND STIFF KNEE, WITH A LIMITED RANGE OF MOTION. BONE SCANS SHOW AN UPTAKE AROUND THE FEMORAL COMPONENT INDICATING A POSSIBLE LOOSE FEMORAL COMPONENT. A DECISION WAS MADE TO REVISE THE FEMORAL COMPONENT AND BEARING ON (B)(6) 2020. ON OPENING THE KNEE, THE FEMORAL COMPONENT WAS NOT OVERTLY LOOSE AND DID REQUIRE A LITTLE WORK TO REMOVE. IT WAS, HOWEVER CONSIDERED TO BE LOOSE. A DECISION WAS MADE TO CONVERT THE TC3 FEMUR TO AN S ROM HINGED KNEE (ALLOWING MORE MOBILITY) WHILE LEAVING THE REVISION TIBIAL TRAY IN SITU.

  Patient problems: Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10581856 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2015 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10553776 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE BECAME UNSTABLE, SO DOCTOR CONVERTED TC3 TO LPS DISTAL FEMUR. DOI: (B)(6) 2016, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9818535 ↗

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-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-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-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-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-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-1369-04 · Dec 22, 2003 · Terminated
  P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703