SIGMA AOX 1961-92-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295076179), received between Dec 14, 2017 and Feb 17, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 32 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BILATERAL KNEE INFECTION. BOTH SIDES WERE SWAPPED OUT FOR NEW POLY. ON THE RIGHT SIDE, THERE WERE NO 3X17.5 RP CVD POLY AVAILABLE DUE TO BACK ORDER. THE POST WAS SHAVED OFF A 3X17.5 RPPS TO REPLICATE A CVD POLY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24364540 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2022, DATE OF REVISION: UNK, DATE OF EVENT: (B)(6) 2024, (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 19173737 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE AND THE POLY WAS SWAPPED FOR A THICKER SIZE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- JANUARY 09, 2024. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18526256 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2015, DATE OF REVISION: (B)(6) 2023, (RIGHT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 18291106 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TKA , CONSTRUCT BECAME UNSTABLE FOR UNKNOWN REASONS. POLY SWAP 3 X 12.5 FOR 3 X 17.5 WAS PERFORMED. NO OTHER INFORMATION AVAILABLE FOR THIS CASE. DOI: (B)(6) 2015. DOR:(B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18284374 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2022; DATE OF REVISION: (B)(6) 2023; (LEFT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 17775516 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. EXPLANTED A 12.5 POLY AND IMPLANTED A 17.5. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17774691 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 17661065 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INSTABILITY ISSUE IN FLEXION. SURGEON DECIDED IT BEST TO REMOVE THE CURRENT POLY, 12.5, AND UPSIZE, 17.5, TO ADDRESS THIS ISSUE. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17623188 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6)2022, DATE OF REVISION: UNK, DATE OF EVENT: (B)(6) 2023, (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 17449821 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO CLUNK. DATE OF IMPLANT: (B)(6) 2016. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 17239687 ↗
• InjuryJun 27, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED AND STATED THAT ON (B)(6) 2021, THE PATIENT RECEIVED BILATERAL TOTAL KNEE REPLACEMENTS UTILIZING J&J DEPUY SIGMA, WITH PRESS-FIT FEMURS AND CEMENTED TIBIAL TRAY AND PATELLA IMPLANTS. INSERTS WERE CURVED CRUCIATE RETAINING DEVICES. THERE WERE NO REPORTED COMPLICATIONS. ON (B)(6) 2023, THE PATIENT WAS SEEN IN THE CLINIC FOR A PREOP EVALUATION. THERE WAS A GROSS FAILURE OF THE ROTATING-PLATFORM KNEE INSERT WITH SIGNIFICANT MEDIAL VARUS LAXITY AND FLEXION INSTABILITY. THE PATIENT WAS SCHEDULED FOR REVISION. ON (B)(6) 2023, THE PATIENT'S LEFT TOTAL KNEE WAS REVISED TO ADDRESS GROSS INSTABILITY, WITH REVISION OF TIBIAL INSERT AND SYNOVECTOMY. THIS APPEARS TO BE RELATED TO AN INJURY SUSTAINED DURING TENNIS, WHERE THE PATIENT HAD A SUDDEN ONSET OF PAIN, DISCOMFORT, SOFT TISSUE DEFORMITY, AND SWELLING. ALL OTHER PRODUCTS BESIDES THE INSERT WERE FOUND TO BE WELL-FIXED AND POSITIONED AND WERE RETAINED.

  Patient problems: Discomfort; Insufficient Information; Joint Laxity; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 17208090 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY EXCHANGE IN SEPTEMBER OF LAST YEAR. UNFORTUNATELY, SHE HAS PROGRESSED TO A CONFIRMED INFECTION. ALL PARTS AND PIECES WERE REMOVED AND A CEMENT SPACER WAS IMPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17050047 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT UNDERWENT A POLY EXCHANGE IN (B)(6) OF LAST YEAR. UNFORTUNATELY, PATIENT HAS PROGRESSED TO A CONFIRMED INFECTION. ALL PARTS AND PIECES WERE REMOVED AND A CEMENT SPACER WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 17049780 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN UNSTABLE KNEE. POLY WAS REPLACED WITH A THICKER POLY. DOI: (B)(6) 2016, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE,

  Patient problems: Joint Laxity

  MAUDE report 16750721 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR MCL TEAR. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16545542 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE I&D POLY EXCHANGED FOR INFECTION. GRAM POSITIVE COCCI. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15233260 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. INSERT WAS REMOVED. DATE OF IMPLANT:(B)(6) 2019, DATE OF REVISION: (B)(6) 2022 (RIGHT AND LEFT SIDE).

  Patient problems: Joint Laxity

  MAUDE report 14772899 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SUPERFICIAL WOUND BREAKDOWN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022 . DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: IV ANTIBIOTICS, IRRIGATION, AND DEBRIDEMENT.

  Patient problems: Erythema; Unspecified Infection; Wound Dehiscence

  MAUDE report 13840840 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13578276 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: TIBIAL INSERT REVISION AND IRRIGATION AND DEBRIDEMENT.

  Patient problems: Fever; Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 13415738 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INDOLENT INFECTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: INVASIVE MEDICAL INTERVENTION - KNEE ASPIRATION: 15 CCC CLOUDY YELLOW FLUID SENT FOR SYNOVASURE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 12689217 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF REVISION #1: (B)(6) 2018 (INSERT REVISED FOR INFECTION), DATE OF REVISION #2: (B)(6) 2020, (LEFT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, TIBIAL INSERT, AND PATELLA IMPLANTS REMOVED, WITH PLACEMENT OF ANTIBIOTIC SPACER.

  Patient problems: No Code Available; Osteolysis; Unspecified Infection

  MAUDE report 10747570 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. IRRIGATION AND DEBRIDEMENT WAS PERFORMED. PATIENT HAD CLOUDY FLUID WHEN CAPSULE WAS ENTERED. CULTURES WERE DRAWN DURING PROCEDURE. NO SURGICAL DELAY IS NOTED. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10379187 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10167378 ↗