SIGMA AOX 1961-92-044Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295076230), received between Sep 14, 2020 and Jul 13, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION ON (B)(6) 2023, DUE TO A DEEP INFECTION. SURGERY DELAY IS UNKNOWN. DATE OF IMPLANT WAS (B)(6) 2020. THIS REPORT IS FOR SIG RP AOX CRV INS SZ4 17.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17321606 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SIGMA RP CONSTRUCT. A POLY WAS SWAPPED IN MAY OF THIS YEAR. THERE IS NOW SUSPICION OF INFECTION. THE RIGHT KNEE WAS IRRIGATED AND THE POLY WAS EXCHANGED FOR A SECOND TIME. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 15849791 ↗
• InjuryMay 9, 2022Unintended Movement; Unintended Movement

  CLINICAL ADVERSE EVENT RECEIVED FOR SPIN OUT VS INSTABILITY WITH PCL COMPROMISE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE.. DATE OF IMPLANTATION: (B)(6) 2022. DATE OF EVENT (ONSET): (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 14336091 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. REMOVAL OF ALL COMPONENTS. DATE OF IMPLANT: (B)(6) 2016, DATE OF IMPLANT (INSERT): (B)(6) 2022, DATE OF REVISION: (B)(6) 2022, (RIGHT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 14193989 ↗
• InjuryJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR IT BAND TENDINITIS EVENT IS SERIOUS. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION (B)(6) /2020. DATE OF EVENT (ONSET): (B)(6) 2021 (LEFT KNEE). TREATMENT: AWAITING A SURGICAL IT BAND RELEASE.

  Patient problems: Inflammation; Joint Laxity; Muscle/Tendon Damage; Pain; Swelling/ Edema

  MAUDE report 13315267 ↗
• InjuryDec 6, 2021Adverse 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 INSTABILITY DATE OF IMPLANTATION: (B)(6) 2020; DATE OF REVISION: (B)(6) 2021; (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 12933214 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2009, DATE OF REVISION #1: (B)(6) 2020 (INSERT REVISED), DATE OF REVISION #2: (B)(6) 2020, (RIGHT KNEE). TREATMENT: EXPLANTATION OF FEMUR, TIBIAL TRAY, TIBIAL INSERT, AND PATELLA PRODUCTS/PLACEMENT OF ANTIBIOTIC SPACER.

  Patient problems: Discomfort; Edema; Fall; Muscular Rigidity; No Code Available; Pain; Unspecified Infection

  MAUDE report 10547515 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2017, DATE OF REVISION: (B)(6) 2020, (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 10538552 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A SIGM CR RP CONSTRUCT SEVERAL YEARS AGO. ON (B)(6) 2020 A POLY EXCHANGE AND WASHOUT WAS DONE. TODAY, PATIENT WAS CONFIRMED FOR INFECTION. ALL IMPLANTS WERE OTHER THAN THE PATELLA AND A SURESPACE CEMENT SPACER WAS UTILIZED. DOI: SOMETIME IN 2009 (FEMORAL & TIBIAL), (B)(6) 2020 (INSERT), DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10531975 ↗