SIGMA 1960-40-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295075042), received between Sep 29, 2017 and Aug 11, 2026 — classified as 47 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (12 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to Knee pain. Possible infection.Activity Level - YesDOI: Unknown.DOR: Unknown .Affected Side: Left Knee.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50216183 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient had an infected total knee. There is no implant record available so no lot codes are provided. All implants were removed. There was no loosening. No more information known.Affected Side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50140007 ↗
• InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE TAKEN OUT DUE TO INFECTION AND ANTIBIOTIC SPACER WAS PUT IN. DOI: (B)(6) 2014. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 25841839 ↗
• InjuryOct 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSE TIBIA AND FEMUR ON THE CEMENT IMPLANT INTERFACE. DOI: (B)(6) 2012 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23352757 ↗
• InjuryDec 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF FEMUR AND TIBIA AT CEMENT TO IMPLANT INTERFACE. SURGICAL DELAY UNKNOWN. FEMUR AND TIBIAL TRAY WERE REVISED TO ADDRESS IMPLANT LOOSENING AT THE CEMENT TO IMPLANT INTERFACE--THE CEMENT MANUFACTURER IS DEPUY. IT IS REASONABLE TO CONCLUDE THAT THE BONE CEMENT, FEMUR AND THE TIBIAL TRAY EACH CAUSED/CONTRIBUTED TO THEIR EVENTS, AS THEIR BONDING INTERFACES ARE PROPERTIES INHERENT TO THE DESIGN AND MANUFACTURE OF EACH DEVICE--NO OTHER KNEE IMPLANTS PLAY ANY ROLE IN MAINTAINING THOSE BONDING INTERFACES. DOI: (B)(6) 2013. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21026246 ↗
• InjuryOct 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PFC IMPLANTS WERE REVISED DUE TO SUSPECTED LOOSENING AT TIBIAL SURFACE.

  Patient problems: Joint Laxity

  MAUDE report 20409617 ↗
• InjuryFeb 20, 2024Use of Device Problem; Use of Device Problem

  PATIENT WAS REVISED DUE TO WEAR ON INSERT AND LOOSENING OF TIBIAL IMPLANT FROM CEMENT. FEMUR WAS ALSO MISPOSITIONED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18739537 ↗
• MalfunctionFeb 5, 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 18639110 ↗
• InjuryJan 31, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAD A REVISION OF LEFT KNEE DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18612979 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. THERE WAS LOOSENING OF THE TIBIA AT CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17487338 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE CLEANING AND RE-REVISION SURGERY AFTER THE CONFIRMATION OF INFECTION. THIS PC REPORTS THE PAIN AND INFECTION AFTER THE REVISION SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED. IT IS ALSO UNKNOWN WHETHER THE IMPLANTS USED IN THE PRIMARY SURGERY ARE JJ PRODUCTS OR NOT. ON (B)(6) 2022, THE REVISION SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. THE REASON FOR THE REVISION IS UNKNOWN. AFTER THE REVISION SURGERY, ON (B)(6) 2023, THE PATIENT CAME TO THE HOSPITAL COMPLAINING OF THE SUDDEN KNEE PAIN, AND THE INFECTION WAS CONFIRMED. NO FURTHER INFORMATION IS AVAILABLE. DOI; (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17116829 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO STAPHYLOCOQUE INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2022; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15502810 ↗
• MalfunctionSep 8, 2022No Apparent Adverse Event; Inaccurate Information; No Apparent Adverse Event; Inaccurate Information

  EVENT DESCRIPTION: AN AR-MEDICA CLIENT CONTACTED US COMPLAINING THAT THE COUNTRY OF ORIGIN DOES NOT MATCH BETWEEN THE SHIPPING INVOICE AND THE BOX LABEL. AT THE MOMENT, CUSTOMS HAS IDENTIFIED 7 CODES IN THE DEPUY BUSINESS WITH SUCH A DISCREPANCY. PHOTOS OF CODES AND SHIPPING INVOICE ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15384497 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE DISTAL FEMUR. FEMORAL COMPONENT AND INSERT REVISED. ORIGINAL SURGERY PERFORMED TO AN UNKNOWN DATE PROBABLY 15 PLUS YEARS AGO. TIBIAL AND PATELLA COMPONENTS WERE WELL FIXED AND NOT REVISED. DOI: PROBABLY 15 PLUS YEARS AGO. DOR: (B)(6) 2022. LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 15028317 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMORAL COMPONENT WAS REVISED DUE TO PAIN. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13903944 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12539657 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFFNESS. PATIENT WAS ONLY ABLE TO EXTEND HER KNEE APPROXIMATELY SEVENTY DEGREES, ACCORDING TO THE SURGEON WHO PERFORMED THIS PATIENT'S PRIMARY AND REVISION PROCEDURE. THE PATIENT'S PRIMARY SIGMA COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. DOI: (B)(6) 2008. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 12373119 ↗
• InjuryAug 6, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. NO CEMENT ATTACHED TO FEMORAL COMPONENT. TIBIA WAS REVISED PREVIOUSLY IN AMES, IA MARY GREELEY MEDICAL CENTER. NO DATES WERE FOUND FOR PRIMARY AND REVISION TIBIAL SURGERIES. SURGEON IS NOW RETIRED AND CAN¿T CONTACT. DOI: UNKNOWN, DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12288658 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. NO LOOSENING REPORTED. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11764433 ↗
• InjuryApr 8, 2021Fracture; Naturally Worn; Fracture; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY REVISION DUE TO INFECTION.

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

  MAUDE report 11633890 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS ASEPTIC LOOSENING. DATE OF IMPLANTATION: (B)(6) 2015, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND INSERT WERE REVISED. ON (B)(6) 2015, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS SEVERE DEGENERATIVE ARTHRITIS, AND CHRONIC QUADRICEPS TENDON DYSFUNCTION. ON (B)(6) 2021, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS PAIN AND FAILED LEFT TOTAL KNEE ARTHROPLASTY DUE TO ASEPTIC LOOSENING. PREOPERATIVELY THE PATIENT WAS NOTED TO HAVE EXPERIENCED PAIN, INSTABILITY, AND DIFFICULTY WITH AMBULATION, THE OPERATIVE FINDINGS INCLUDED: GROSSLY LOOSE FEMUR AT THE CEMENT/BONE INTERFACE. THE TIBIAL TRAY WAS LOOSE AT THE IMPLANT/CEMENT INTERFACE. THE TIBIAL TRAY HAD DRIFTED INTO SIGNIFICANT VARUS AND THERE WAS SIGNIFICANT SYNOVIUM. THERE WAS A LARGE CYSTIC AREA NOTED IN THE TIBIA. THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENTS WERE REVISED. THE PATIENT DID NOT HAVE A PATELLA. DOI: (B)(6) 2015, DOR: (B)(6) 2021 (LEFT KNEE).

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 11436202 ↗
• InjuryDec 28, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2011; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11077154 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2011. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10874542 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE SURGEON ELECTED TO CHANGE THE FEMUR TO A TC3 FEMUR AND POLY. DOI: (B)(6) 2014, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10307875 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED LEFT KNEE. REMOVAL DATE: (B)(6) 2020. PATIENT STATUS/ OUTCOME / CONSEQUENCES UNKNOWN, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFECTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, ACTIVITY LEVEL HIGH, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10259471 ↗