SIGMA 1960-50-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295075134), received between Aug 29, 2017 and Aug 20, 2025 — classified as 42 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (14 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT VOLUNTARY REPORT WAS RECEIVED (B)(4). ORIGINAL SURGERY DATE FOR RIGHT TOTAL KNEE ARTHROPLASTY (B)(6) 2021. PATIENT REQUIRED A KNEE REPLACEMENT (B)(6) 2025. WHEN THE OLD KNEE REPLACEMENT WAS REMOVED, THERE WAS SIGNIFICANT DAMAGE TO THE JOINT WHICH WAS NOT EXPECTED AND SEEMED TO BE A MANUFACTURING DEFECT. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 22849313 ↗
• InjuryMay 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FEMUR AND TIBIA LOOSENING ON THE IMPLANT CEMENT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22068687 ↗
• InjuryMay 20, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FEMUR AND TIBIA LOOSENING ON THE IMPLANT CEMENT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22051066 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFFNESS AND PAIN. NO LOOSE IMPLANT INTERFACES. DOI: (B)(6) 2015 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 20521580 ↗
• MalfunctionFeb 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT REPORTED: "I AM CURRENTLY LIVING IN SYRIA. IN (B)(6) 2021, I HAD SURGERY ON BOTH MY RIGHT AND LEFT KNEES. THE SURGEON RECOMMENDED IT BECAUSE HE CONNECTED AND HAS AN AGREEMENT WITH THE IMPORTING COMPANY, AND WE AGREED TO USE JOHNSON & JOHNSON'S IMPLANTS AS YOUR COMPANY IS KNOWN FOR ITS WORLD-CLASS PRODUCTS AND STELLAR REPUTATION. MY CONDITION SINCE THE SURGERY HAS BECOME WORSE THAN IT WAS BEFORE. NOWADAYS, ESPECIALLY THE RIGHT ONE, I GET TIRED AFTER WALKING A SHORT DISTANCE AND WOULD NEED TO LEAN ON SOMEONE. CURRENTLY, I AM EXPERIENCING EXCRUCIATING PAIN IN BOTH OF MY KNEES THAT HAVE BECOME SWOLLEN. PLEASE NOTE THAT BEFORE THE SURGERY, I NEVER EXPERIENCED THESE SYMPTOMS. THE SURGEON WHO PERFORMED THE PROCEDURE AND THE COMPANY IS NOT PROVIDING A LOGICAL EXPLANATION FOR WHY I AM EXPERIENCING PAIN."

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 18649257 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT KNEE PAIN. DOI: UNKNOWN; DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18283164 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18209207 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD REVISION SIGMA COMPONENTS CURRENTLY IMPLANTED BUT THE TIBIAL COMPONENT HAD FALLEN INTO VARUS AND THE TIBIAL STEM WAS PROTRUDING OUT OF THE LATERAL CORTEX OF THE TIBIA. THIS PATIENT ALSO HAD STABILITY ISSUES SO SURGEON REMOVED BOTH THE TIBIAL AND FEMORAL COMPONENTS AND REPLACED THEM WITH AN ATTUNE REVISION TIBIAL TRAY, STEM, AND SLEEVE. DOI: UNKNOWN. DOR: (B)(6),2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17443707 ↗
• MalfunctionJun 21, 2023Device Damaged Prior to Use; Unexpected Color; Device Damaged Prior to Use; Unexpected Color

  IT WAS REPORTED ON (B)(6) 2023, THAT WHEN THE SURGEON OPENED THE IMPLANT, IT WAS NOTICED THAT THERE WAS MODERATE DISCOLORATION ON THE FEMORAL IMPLANT (DARKER COLOR DISCOLORATION, LIKE THE IMPLANT WAS WET). IT WAS FELT AT THE INSIDE OF BOTH PACKAGES IN WHICH THE IMPLANT COMES IN, AND THERE WAS NO VISUAL SIGN OF ANY MOISTURE OR THE PACKAGE BEING PREVIOUSLY WET. THE SURGEON DID NOT FEEL COMFORTABLE USING THIS IMPLANT AND IT WAS PASSED OFF OF THE SURGICAL FIELD. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. AFFECTED SIDE: RIGHT KNEE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171188 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A SIGMA TOTAL KNEE, BUT SURGEON WAS UNSURE OF WHO THE ORIGINAL IMPLANTING SURGEON WAS. HE ALSO WAS UNSURE OF WHEN THE PATIENT HAD THEIR ORIGINAL SURGERY DONE AND WHERE IT WAS DONE. THE PATIENTS KNEE WAS GROSSLY UNSTABLE AND SURGEON FELT THEY WOULD BENEFIT FROM A FULL TEAR OUT AND PLACEMENT OF AN ATTUNE REVISION. THE KNEE WAS FULLY REVISED TO A FB ATTUNE REVISION AND STABILITY WAS ACHIEVED THROUGH FULL RANGE OF MOTION. CLOSING PROCESS BEGAN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16745309 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. SIGMA IMPLANTS WERE EXPLANTED. CEMENT SPACER WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16246308 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. SURGEON DISTALIZED THE PATIENT'S FEMORAL COMPONENT AND REVISED THE FEMORAL & INSERT. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13415652 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT RESECTION WAS PERFORMED FOR INFECTION. DOI: (B)(6) 2017, DOR: UNKNOWN; RIGHT KNEE.

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

  MAUDE report 12437953 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. FAILED RIGHT TOTAL KNEE. DOI: (B)(6) 2017, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12316044 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT A PRIMARY BILATERAL KNEE ARTHROPLASTY TO ADDRESS SEVERE DEGENERATIVE GONARTHROSIS AND CHONDROMALACIA. THE PATELLA WAS RESURFACED AND DEPUY PRODUCTS WERE IMPLANTED WITH DEPUY CEMENT X 1 FOR EACH KNEE. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS PAIN AND TIBIAL TRAY SUBSIDENCE. THE SURGEON NOTED REMOVAL OF SCAR TISSUE. THE TIBIAL TRAY TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2012. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 12125940 ↗
• InjuryJul 6, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PRIMARY OPERATIVE NOTES (B)(6) 2012 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2014 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO LOOSE TOTAL KNEE ARTHROPLASTY. UPON ENTERING THE JOINT, SYNOVITIS AND SCAR TISSUE WAS ENCOUNTERED AND REMOVED. THE FEMORAL COMPONENT WAS LOOSE AS WELL AS THE FEMORAL TIBIAL COMPONENT ¿ INTERFACE NOT PROVIDED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2012, DOR: (B)(6) 2014, RIGHT KNEE.

  Patient problems: Adhesion(s); Synovitis

  MAUDE report 12122698 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2017, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12036351 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LACK OF MOTION AND PATELLA TRACKING. NO LOOSENING REPORTED. NO DELAYS DURING SURGERY. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 11862662 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS INFECTION. REMOVED IMPLANTS AND PLACED NEW IMPLANTS. LOOSENING IS UNKNOWN AND NO DELAY IN SURGERY REPORTED. UNKNOWN CEMENT MANUFACTURER. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 11786054 ↗
• InjuryMar 30, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN IN KNEE. BONE SCANS/X RAYS INDICATED SIGNS OF LOOSENING. SURGEON PULLED OLD IMPLANTS AND REVISED TO A NEW CONSTRUCT. LOOSENING WAS REPORTED AT TIBIAL AND FEMORAL COMPONENT AT BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. AN UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2014, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11589126 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATENT'S KNEE WAS REVISED DUE TO FLEXION EXTENSION MISMATCH. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2012; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11008668 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY ISSUES. A REVISION KNEE WAS REPLACED. ORIGINAL IMPLANT DATE AND LOT NUMBERS ON IMPLANTS THAT WERE REMOVED ARE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10852047 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND POLY WEAR. A REVISION TO AN ATTUNE REVISION KNEE WITH SLEEVES, STEMS AND RP REVISION TIBIAL COMPONENT WAS DONE. NO FURTHER INFORMATION AVAILABLE. DOI: 20 YEARS AGO, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10278183 ↗
• InjuryJul 14, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED FOR PAIN AND POSSIBLE LOOSE FEMUR. EXTRACTED THE OLD FEMUR AND RP INSERT. IMPLANTED A NEW FEMUR WITH AUGMENTS, SLEEVE, STEM AND NEW RP INSERT. ORIGINAL DOS WAS (B)(6) 2012 ON THE PATIENTS RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10271102 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS DISTAL FEMUR FRACTURE DUE TO FALL. HER ENTIRE DISTAL FEMUR WAS REPLACED WITH A DEPUY LIMB PRESERVATION SYSTEM (LPS) DISTAL FEMORAL COMPONENT AND AN LPS STRAIGHT CEMENTED STEM. HER PROXIMAL TIBIA ALSO HAD TO BE REVISED, SINCE HER PRIMARY TIBIAL TRAY AND INSERT WERE NOT COMPATIBLE WITH HER NEW LPS DISTAL FEMORAL COMPONENT. A COMPATIBLE ATTUNE REVISION ROTATING PLATFORM TIBIAL BASE WITH A CEMENTED STEM, AND AN ATTUNE LPS INSERT WERE IMPLANTED DURING THE REVISION PROCEDURE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall; No Code Available

  MAUDE report 10252288 ↗