SIGMA AOX 1961-92-053Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295076261), received between Sep 10, 2018 and Jan 14, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED DUE TO INFECTION. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24071902 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR UNKNOWN REASON. POLY WAS SWAPPED AND WASHED OUT OF TKA WAS PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16598403 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: REVISION (REVISED COMPONENTS NOT SPECIFIED).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 16580999 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST OP MI. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT AND LEFT KNEE). TREATMENT: ORAL MEDICATION (PLAVIX).

  Patient problems: Myocardial Infarction

  MAUDE report 16193820 ↗
• InjuryDec 21, 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 TOTAL KNEE IMPLANT IN 2018. THE PATIENT HAD ONE WASHOUT BETWEEN NOW AND THEN. THE PATIENT WAS CONFIRMED FOR INFECTION AND THE TOTAL KNEE WAS REMOVED AND THE INFECTION IS BEING TREATED WITH ANTIBIOTIC SPACER AND RE-IMPLANT WILL OCCUR WHEN THE INFECTION CLEARS. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16022904 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED KNEE, DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, PATELLA, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16015875 ↗
• InjuryMar 23, 2022Adverse 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) 2022; (LEFT KNEE). TREATMENT: REVISION OF FEMUR, TIBIAL TRAY, TIBIAL INSERT, AND PATELLA.

  Patient problems: Ambulation or Postural Difficulties; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 13860577 ↗
• InjuryOct 18, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Naturally Worn; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ON (B)(6) 2018, THE PATIENT HAD A LEFT CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS END-STAGE LEFT KNEE. DEPUY COMPONENTS INCLUDING DEPUY PATELLA WAS USED DURING THIS PROCEDURE. THERE WERE NO COMPLICATIONS NOTED. ON (B)(6) 2021, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY, TIBIAL COMPONENT TO ADDRESS ACUTE HEMATOGENOUS SEPSIS. THE PATIENT HAS HAD ERYTHEMA, SWELLING, PAIN, FEVER AND CHILLS. PRIOR TO SURGERY, GROSS PUSS WAS ASPIRATED FROM THE KNEE. DURING THE PROCEDURE, THE SURGEON OBSERVED GROSS PUSS. THE SURGEON ALSO NOTED THAT THE POLYETHYLENE INSERT HAD REALLY MINIMAL WEAR. ALL COMPONENTS WERE NOTED TO HAVE BEEN WELL FIXED. ONLY THE INSERT WAS REVISED.

  Patient problems: Chills; Erythema; Fever; No Clinical Signs, Symptoms or Conditions; Pain; Sepsis; Swelling/ Edema; Unspecified Infection

  MAUDE report 12646832 ↗
• InjurySep 27, 2021Naturally Worn; Naturally Worn

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2018, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: REVISION OF THE TIBIAL INSERT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Erythema; Fever; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 12533595 ↗
• InjuryMay 18, 2021Unintended Movement; Noise, Audible; Unintended Movement; Noise, Audible

  MEDICAL RECORDS RECEIVED AND WERE REVIEWED: ON (B)(6) 2021, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY PRODUCTS AND CEMENT WERE USED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A LEFT KNEE EVALUATION DUE TO MULTIPLE OCCURRENCES OF CLUNKING IN HIS KNEE WITH MILD PAIN. ON EXAMINATION, THE PHYSICIAN NOTED WITH DEEP FLEXION PAST 130 DEGREES THERE WAS A TENDENCY FOR THE POLY TIBIAL INSERT TO SPIN OUT. WHEN PALPATED, THERE WAS AN AUDIBLE CLUNK WITH SUBLUXATION AND AN AUDIBLE CLUNK WHEN IT SUBLUXED BACK INTO THE JOINT. IT WAS NOTED THIS CAN BE REPRODUCED WITH FLEXION PAST 130. THE PHYSICIAN INDICATED AT THAT POINT THE PATIENT WAS EXPERIENCING POLY SUBLUXATION, BUT HAD NOT FORMERLY SPUN OUT. PLAN FOR REVISION WITH POLY SWAP AS WELL AS PCL RELEASE. ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS POLY TIBIAL INSERT SUBLUXATION/SPINOUT. THE SURGEON NOTED FINDINGS AS INCREASED FLEXION GAP POSTEROLATERALLY WITH INCREASED FEMORAL ROLLBACK POSTEROLATERALLY. THE PATIENT WAS EXPERIENCING PAIN AND INSTABILITY. THERE WAS A BIT OF A COAGULANT FROM RESOLVING HEMATOMA. THE TIBIAL INSE

  Patient problems: Hematoma; Insufficient Information; Joint Laxity; Pain

  MAUDE report 11841009 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Unintended Movement; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Noise, Audible

  PATIENT WAS REVISED DUE TO HAVING INSTABILITY ISSUES A COUPLE WEEKS AFTER SURGERY. SURGEON DECIDED IT BEST TO INCREASE THE POLY THICKNESS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2021 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Hematoma; Joint Laxity; Pain

  MAUDE report 11783660 ↗
• InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. I & D POLY SWAP WAS PERFORMED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7859520 ↗