SIGMA AOX 1961-92-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295076278), received between Feb 17, 2020 and Aug 17, 2026 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

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

  It was reported that Patient had infected knee. Washout I&D. Poly was swapped from a 5x17.5 RP CVD to 5x20 RPPS. The post was shaved off the RPPS insert by Dr to fit with a CR Femur.Affected side-Right.

  Patient problems: Unspecified Infection

  MAUDE report 50275699 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION. 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: (B)(6) 2023, DATE OF EVENT: (B)(6) 2023, (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16823998 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 14696337 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR COMPLETE WOUND BREAKDOWN WITH EXTENSOR MECHANISM EXPOSED, FOUL SMELLING. UNSURE IF THIS COMMUNICATES WITH THE JOINT OR NOT AT THIS POINT. WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: PICC LINE FOR IV ANTIBIOTICS, REFERRED TO PLASTICS FOR GASTROC FLAP COVERAGE.

  Patient problems: Fluid Discharge; Impaired Healing; Necrosis; Wound Dehiscence

  MAUDE report 13824556 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE: MEDICAL RECORDS RECEIVED ON AD 13 MAR 2020 PATIENT RECEIVED A DEPUY PFC SIGMA RP TOTAL KNEE TO TREAT END-STAGE VALGUS OSTEOARTHRITIS OF THE RIGHT KNEE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT WAS UTILIZED. INTRAOPERATIVELY, THE SURGEON REPAIRED A NATURAL TIBIAL DEFECT WITH 2 UNKNOWN FULLY THREADED SCREWS AND CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2020 WITH PAIN, SWELLING, AND STIFFNESS SECONDARY TO SUPERFICIAL WOUND INFECTION. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. RIGHT KNEE X-RAYS IDENTIFIED SUBCUTANEOUS EMPHYSEMA. THE PATIENT DID NOT FOLLOW POSTOPERATIVE TREATMENT AND ANTIBIOTIC TREATMENT PROTOCOL AND THE INFECTION BECAME DEEP, REQUIRING SURGICAL INTERVENTION. DOR: (B)(6) 2020: PATIENT REVISED TO TREAT DEEP INFECTION. UPON ENTERING THE KNEE, THE SURGEON ENCOUNTERED AND EVACUATED PUS. A COMPLETE SYNOVECTOMY WAS PERFORMED, AND SCAR TISSUE WAS DEBRIDED. THERE WERE NO REPORTED PRODUCT PROBLEMS WITH THE REVISED INSERT OR THE RETAINED PATELLA, FEMORAL COMPONENT, OR TIBIAL TRAY. THE PATIENT WAS REVISED WITH A DEPUY INSERT AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT WAS INSTRUCTE

  Patient problems: Adhesion(s); Edema; Muscular Rigidity; No Code Available; Pain; Unspecified Infection

  MAUDE report 9848813 ↗
• InjuryFeb 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON DID AN I & D WASHOUT WITH POLY EXCHANGE. A 5X17.5 WAS RE-IMPLANTED. DOI: UNKNOWN; DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9718702 ↗