SIGMA AOX 1961-92-022Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295076131), received between May 19, 2020 and Jan 13, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LATERAL KNEE PAIN. POLY WAS SWAPPED FROM 12.5 TO 17.5. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR:(B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21143029 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2023. (RIGHT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL BASE, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 18073936 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FAILING SUPPRESSION; INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2005. DATE OF REVISION #1: (B)(6) 2022. DATE OF REVISION #2: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 17728402 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SIGMA CR RP CONSTRUCT AT SOME POINT IN THE PAST. HER MOST RECENT SURGERY ON THIS KNEE WAS ON (B)(6) 2022 WHERE A WASHOUT WAS PERFORMED AND A 2.5/12.5 CR RP INSERT WAS IMPLANTED. THEN SHE WAS CONFIRMED FOR INFECTION AND ALL PARTS AND PIECES WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17718998 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS LOOSE VARUS/VALGUS SO SURGEON PUT IN A 15MM POLY. DOI: JAN 22, 2020. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17689281 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A GLOBALLY UNSTABLE KNEE. SURGEON REMOVED THE POLY AND UPSIZED TO MAKE THE KNEE STABLE. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15698347 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 THE PATIENT HAD A LEFT TOTAL CEMENTED KNEE ARTHROPLASTY TO ADDRESS END-STAGE ARTHROSIS. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT WERE USED DURING THIS PROCEDURE. ON (B)(6) 2022 MEDICAL RECORDS NOTE THE PATIENT IS STATUS POST LEFT KNEE REPLACEMENT WITH NEW ONSET PAIN AND POPPING. INITIAL SURGERY WAS 5 MONTHS AGO, THEN THE PATIENT WAS SEPTIC POSTOPERATIVELY AND PNEUMONIA AS WELL AS C. DIFFICILE. IT WAS NOTED ON PHYSICAL EXAMINATION THAT THE PATIENT HAS LOTS OF VALGUS LAXITY. THE IMPRESSION IS THAT THE PATIENT HAS STATUS POST LEFT KNEE REPLACEMENT WITH MCL INJURY AND LIKELY SPINNING OUT OF POLY.

  Patient problems: Pneumonia; Unspecified Infection

  MAUDE report 15455665 ↗
• InjurySep 8, 2022Adverse 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 AND THERE IS A REMOTE POSSIBILITY THAT IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Joint Laxity; Swelling/ Edema

  MAUDE report 15378573 ↗
• InjurySep 1, 2022Unintended Movement; Unintended Movement

  CLINICAL ADVERSE EVENT RECEIVED FOR SPIN OUT EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2022. DATE OF EVENT (ONSET): (B)(6) 2022. (LEFT KNEE) TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Insufficient Information; Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 15341203 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14288525 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2022, DATE OF REVISION: NOT PROVIDED, (LEFT KNEE), TREATMENT: REVISION OF THE TIBIAL INSERT.

  Patient problems: Joint Laxity; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 13930957 ↗
• InjuryFeb 1, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY WITH LARGE ANTERIOR DRAWER WITH DISLOCATION OF POLY. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF REVISION: (B)(6) 2022; (LEFT KNEE). TREATMENT: REVISION OF THE TIBIAL INSERT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation; Joint Laxity

  MAUDE report 13414695 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 12780014 ↗
• InjuryMay 24, 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 INSTABILITY AND PAIN/STIFFNESS DATE OF IMPLANTATION: (B)(6) 2017 DATE OF REVISION: (B)(6) 2021 (LEFT KNEE) ON (B)(6) 2017, PATIENT RECEIVED BILATERAL PFC SIGMA CEMENTED POSTERIOR CRUTIATE RETAINING, ROTATING PLATFORM TOTAL KNEE REPLACEMENTS TO ADDRESS SIGNIFICANT PAIN & DISCOMFORT, DYSFUNCTION, AND BONE-ON-BONE ARTHRITIS AND CHONDROSIS. PATELLAS WERE RESURFACED IN BOTH CASES. THERE WERE NO REPORTED COMPLICATIONS FOR EITHER KNEE. PATIENT WAS SEEN IN THE PHYSICIANS OFFICE FOR CLINICAL FOLLOW-UP ON (B)(6) 2021. SHE PRESENTED WITH A PAINFUL, UNSTABLE LEFT KNEE. HER DIAGNOSIS IS GLOBAL INSTABILITY OF THE LEFT, WITH PLAN TO REVISE FOLLOWING THE RAISING OF COVID 19 RESTRICTIONS. ON (B)(6) 2021, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS MODERATE GLOBAL INSTABILITY WITH SIGNIFICANT SCARRING/ARTHROFIBROSIS. TIBIAL INSERT WAS REVISED, AND AN EXTENSIVE SCAR RESECTION/SYNOVECTOMY WAS PERFORMED. THERE WERE NO COMPLICATIONS REPORTED. TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Adhesion(s); Joint Laxity; Muscular Rigidity; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11870018 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A BILATERAL SIGMA RP CONSTRUCT BACK IN 2017. HAS DONE WELL WITH BOTH KNEES UNTIL RECENTLY THE LEFT SIDE HAS LOOSENED UP ON A BIT. THE 12.5 MM WAS REVISED TO A THICKER POLY TO MAKE THE KNEE MORE STABLE A 15 MM. DOI: (B)(6) 2017. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11833089 ↗
• InjuryMay 14, 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) 2020 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11826270 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT'S RIGHT KNEE WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE FEMUR AND TIBIAL TRAY COMPONENTS, ALONG WITH ARTHROFIBROSIS. FEMUR, TIBIAL TRAY, AND TIBIAL INSERT COMPONENTS WERE REVISED, AND DEPUY ATTUNE REVISION COMPONENTS RE-IMPLANTED TO TREAT.

  Patient problems: Fibrosis; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 11804551 ↗
• InjuryMar 10, 2021Unintended Movement; Unintended Movement

  STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POLY SPIN OUT. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS PROBABLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2013, DATE OF EVENT: (B)(6) 2020, (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Insufficient Information

  MAUDE report 11457238 ↗
• InjuryOct 13, 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: No Code Available; Pain

  MAUDE report 10670498 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GLOBAL INSTABILITY; STATUS POST FALL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: REVISION OF INSERT.

  Patient problems: Fall; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10649844 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR OPEN INCISION: WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: KEFLEX AND IODOFORM GAUZE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 10476562 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. IT WAS REPORTED BY THE PATIENT THAT SHE HAD BILATERAL KNEES WITH ONGOING PAIN. HER RIGHT KNEE FEELS LIKE IT IS ¿SLIPPING OUT OF PLACE". SHE HAS HAD A DEPUY RIGHT SHOULDER IN 2010 THAT HAS ONGOING PAIN AND ¿SLIPS OUT OF PLACE¿. NO KNOWN INTERVENTIONS HAVE BEEN PERFORMED. SHE IS REQUESTING COMPENSATION.

  Patient problems: No Code Available; Pain

  MAUDE report 10072932 ↗