SIGMA 96-0089Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295232568), received between Jul 18, 2017 and Jan 12, 2026 — classified as 45 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (15 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Loss of or Failure to Bond

  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: (B)(6) 2016. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 24039331 ↗
• 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 23543434 ↗
• InjuryJul 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT WAS DUE TO BONE LOSS. CONVERTED TO A DFR. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching

  MAUDE report 22484327 ↗
• InjuryApr 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE ASEPTIC LOOSENING. REMOVED ALL IMPLANTS AND CONVERTED TO ATTUNE REVISION KNEE IMPLANTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21892747 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE. SURGEON SWITCHED THE FEMUR TO A HINGE CONSTRUCT DUE TO COLLATERAL LIGAMENT DEFICIENCIES. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21057411 ↗
• 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 20645643 ↗
• InjuryAug 14, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE AND FEMORAL COMPONENT WAS LOOSE AT THE UNKNOWN INTERFACE. DOI: (B)(6) 2018. DOR: UNKNOWN. AFFECTED SIDE: RIGHT FEMUR.

  Patient problems: Joint Laxity

  MAUDE report 19981980 ↗
• 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: JAN 17, 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18569566 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND STERLING AND WAS TESTED FOR NICKEL ALLERGY. THE TEST CAME BACK POSITIVE SO THE SURGEON TOOK IT ALL OUT AND PUT IN AN AESCULAP REVISION CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16585051 ↗
• InjuryDec 22, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE UNKNOWN COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT BROKE THE ADAPTOR AND ADAPTOR BOLT FOR THE SECOND TIME. BONE HAS RESORBED AROUND THE IMPLANT CREATING ALMOST A DISTAL FEMORAL REPLACEMENT SITUATION. ADAPTOR BOLT, ADAPTOR, FEMORAL COMPONENT AND INSERT WERE REMOVED LEAVING THE TIBIAL COMPONENT AND FEMORAL SLEEVE AND STEM WELL FIXED IN THE PATIENT. A HINGED COMPONENT WAS THEN PREPPED FOR AND IMPACTED INTO THE SLEEVE THAT WAS WELL FIXED IN THE BONE AND A LPS INSERT WAS INSERTED. DOI: (B)(6) 2017. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16033324 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT KNEE. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15586838 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO ARTHROFIBROSIS. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2011, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 12721245 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL & TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. REMOVAL OF ALL IMPLANTS DUE TO CEMENT COULDN'T SEE MOST NUMBERS. ONLY ABLE TO OBTAIN THE NUMBERS FROM FEMORAL STEM, TC3 RP INSERT AND THE THICK TRAY. ALL OTHER PARTS WERE COVERED BY CEMENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 12517246 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL IMPLANT EXPLANTED, CONVERT TO ANTIBIOTIC SPACER DUE TO INFECTION. POLY INSERT CHANGED ON (B)(6) 2019 FROM PREVIOUS INFECTION. DOI: (B)(6) 2019 ALL EXPLANTED PRODUCTS, DOI: (B)(6) 2019 TIBIAL INSERT, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11917881 ↗
• InjuryMay 27, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  "THE ABOVE MENTIONED KNEE ENDOPROSTHESIS WAS IMPLANTED IN (B)(6) IN 2002. SINCE 2013 LOOSENING OF THE PROSTHESIS AND FRACTURE OF THE TIBIAL STEM IS KNOWN. DUE TO MULTIPLE INTERNAL DISEASES THE PATIENT WAS NOT ABLE TO UNDERGO SURGERY UP TO NOW. NOW, KNEE-TEP REMOVAL WAS PERFORMED BECAUSE OF KNEE-TEP LOOSENING AND STEM-FRACTURE." DOI: (B)(6) 2002, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11893254 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE TOTAL REVISION DUE TO MULTIPLE ISSUES INVOLVING AN UNKNOWN MANUFACTURER KNEE SYSTEM. DEPUY PRODUCTS AND CEMENT WERE USED DURING THE OPERATION. THE SURGEON NOTED WHILE IMPLANTING THE TIBIAL COMPONENT THE CREATION OF A SMALL CRACK ANTERIOR MEDIAL IN THE TIBIA. IT WAS LESS THAN A MILLIMETER. IT WAS EXTREMELY STABLE AND DID NOT REQUIRE FIXATION OR INTERVENTION. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH REMOVAL OF RIGHT TOTAL KNEE IMPLANTS, ALL COMPONENTS, COMPLETE SYNOVECTOMY AND AGGRESSIVE DEBRIDEMENT, AND PLACEMENT OF TEMPORARY ANTIBIOTIC LOADED SPACER CONTAINING GENTAMICIN AND VANCOMYCIN ANTIBIOTIC TO ADDRESS RECURRENT INFECTION. THE SURGEON NOTED THE REMOVAL OF FIBROUS TISSUE.

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

  MAUDE report 11687210 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED FOR AN EVALUATION DUE TO RIGHT KNEE PAIN, SWELLING, SYNOVITIS, AND WARMTH. THE PHYSICIAN NOTED THE ASPIRATION OF 10 ML OF CLOUDY SLIGHTLY BROWNISH FLUID. THE PHYSICIAN INDICATED THE FLUID WOULD BE SENT OFF FOR CULTURES AND CELL COUNT. IT WAS ALSO NOTED THE PATIENT WOULD HAVE BLOOD WORK COMPLETED. THE PHYSICIAN INDICATED THE PATIENT WAS ON ORAL SUPPRESSION WITH DOXYCYCLINE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 11516481 ↗
• MalfunctionOct 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ORIGINAL TKA WAS AN INTERMEDICS DONE IN SALT LAKE CITY.

  Patient problems: Adhesion(s); Discomfort; Edema; No Code Available; Pain

  MAUDE report 10646422 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014 THE PATIENT UNDERWENT A MEDIAL UNICOMPARTMENTAL TOTAL KNEE TO ADDRESS THE PREOPERATIVE DIAGNOSIS OF MEDIAL COMPARTMENT OSTEOARTHRITIS, RIGHT KNEE. NO COMPLICATIONS NOTED. MEDICAL RECORDS FROM (B)(6) 2019 NOTED THAT SINCE THE REVISION ON (B)(6) 2016, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING, EFFUSION, AND HAS HAD AN ASPIRATION PERFORMED. SURGEON NOTED A CONCERN FOR LOOSENING OF COMPONENTS, AS WELL AS OSTEOLYSIS VERSUS POSSIBLE INFECTION. RADIOGRAPHS WERE REPORTED TO SHOW POSSIBLE LOOSENING. AT THE TIME OF THIS REVIEW, THERE WERE NO REVISION INFORMATION.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 10514691 ↗
• InjuryAug 18, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESSED LOOSENING OF THE FEMORAL COMPONENT AT CEMENT TO IMPLANT AND BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED. ALSO, IT WAS REPORTED THAT THE ADAPTER BOLT +2/-2 AND 5 DEGREE ADAPTER BOTH BROKE, CAUSING THE TC3 FEMUR TO COME LOOSE AWAY FROM THE FEMORAL SLEEVE. DOI: (B)(6) 2017, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10422299 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED STAGE 1 OF A TWO-STAGE REVISION OF THE RIGHT KNEE TO TREAT PAIN, SWELLING, WALKING DIFFICULTY, AND PRURITIS SECONDARY CHRONIC INFECTION PROGRESSING TO SEVERE SEPSIS. UPON ENTERING THE JOINT, THE SURGEON ENCOUNTERS AND REMOVED GROSS PURULENCE FROM THE JOINT. SIGNIFICANT SYNOVITIS AND INFECTED TISSUE WERE DEBRIDED. ALL COMPONENTS WERE EXPLANTED AND REPLACED WITH DEPUY PRODUCTS AND COMPETITOR CEMENT X 5, AND STIMULAN ANTIBIOTIC BEADS. THE PATIENT WAS IMPLANTED WITH DEPUY PRODUCTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT WAS PLACED ON 6-WEEK IV ANTIBIOTICS. STAGE TWO REVISION IS SCHEDULED FOR 6 WEEKS, PENDING CLEARANCE OF INFECTION. DOI: (B)(6) 2016 (PATELLA). DOI: (B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS). DOE: (B)(6) 2018 (WOUND DEBRIDEMENT). DOE: (B)(6) 2019 (DECOMPRESSION). DOR: (B)(6) 2019 (INSERT EXCHANGE). DOE: (B)(6) 2019 (WOUND DEHISCENCE REPAIR). DOR: (B)(6) 2020 (STAGE 1 REVISION). RIGHT KNEE.

  Patient problems: Edema; Fever; Itching Sensation; No Code Available; Pain; Sepsis; Unspecified Infection

  MAUDE report 10247599 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT KNEE BONE DECOMPRESSION TO TREAT PAIN AND WALKING DIFFICULTY SECONDARY TO HETEROTOPIC OSSIFICATION. INTRAOPERATIVELY, THE SURGEON REMOVED ANTERIOR SUPRAPATELLAR BONE SPURS AND ADHESIONS AND PERFORMED A SYNOVECTOMY. ALL COMPONENTS WERE WELL-FIXED AND RETAINED. THE PATIENT RECEIVED AN ANTERIOR ADDUCTOR CANAL NERVE BLOCK CATHETER FOR POSTOPERATIVE PAIN RELIEF. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATHOLOGY OF THE EXCISED TISSUE WAS BENIGN, AND NO INFECTION WAS IDENTIFIED. NO COMPONENTS WERE REVISED. DOI: (B)(6) 2016 (PATELLA). DOI: (B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS). DOE: (B)(6) 2018 (WOUND DEBRIDEMENT). DOE: (B)(6) 2019 (DECOMPRESSION). RIGHT KNEE.

  Patient problems: Adhesion(s); Edema; Extraskeletal ossification; No Code Available; Pain

  MAUDE report 10247508 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVES A RIGHT KNEE SUPERFICIAL INCISION AND DEBRIDEMENT TO TREAT PAIN, SWELLING, AND PURULENT DRAINAGE SECONDARY TO POSTOPERATIVE SUPERFICIAL CUTANEOUS ABSCESS. RADIOGRAPHIC IMAGING IDENTIFIES A WELL-FIXED AND STABLE TC3 REVISION KNEE. THE PROCEDURE WAS DONE IN BY A WOUND CARE SPECIALIST. THE PATIENT IS TO CONTINUE ORAL ANTIBIOTIC TREATMENT. NO PRODUCTS WERE REVISED. DOI: (B)(6) 2016 (PATELLA), DOI: (B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS), DOE: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Abscess; Edema; Fluid Discharge; Impaired Healing; No Code Available; Pain

  MAUDE report 10247197 ↗
• InjuryJul 2, 2020Noise, Audible; Noise, Audible

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA CLUNK SYNDROME. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: ARTHROSCOPY.

  Patient problems: No Code Available

  MAUDE report 10224390 ↗
• InjuryMay 8, 2020Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  BROKEN ADAPTER BROKEN BOLT AND LOOSE FEMUR.

  Patient problems: No Code Available; Pain

  MAUDE report 10039032 ↗

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-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-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-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-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-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-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