SIGMA AOX 1961-92-043Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295076223), received between Jan 24, 2018 and Jan 25, 2024 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, LEFT KNEE WAS REVISED TO ADDRESS ACUTE POSTOPERATIVE SEPSIS (INFECTION). THIS IS AFTER THE PATIENT HAD ALREADY BEEN TREATED WITH AN EXTERNAL FIXATOR FOR A HIGH ENERGY PROXIMAL TIBIA FRACTURE, FOLLOWED BY REVISION OF THE TIBIAL TRAY AND INSERT WITH ATTUNE REVISION CRS KNEE IMPLANTS, AND ORIF PLACEMENT OF TWO SMALL FRAGMENT PLATES AND SCREWS (MANUFACTURER NOT PROVIDED). THOSE EVENTS OCCURRED APPROXIMATELY 4 WEEKS PRIOR TO THE CURRENT EVENT. THE PATIENT NOW PRESENTED WITH ACUTE SEPSIS OF THE KNEE JOINT, WITH PAIN, DISCOMFORT, SIGNIFICANT STIFFNESS, ERYTHEMA, WOUND DRAINAGE AND SWELLING, SURGICALLY, THE PATIENT'S LEFT KNEE WAS IRRIGATED AND DEBRIDED WITH SYNOVECTOMY. ALL IMPLANTS APPEARED TO BE DOING WELL WITH REGARD TO INGROWTH AND FIXATION. THE INSERT WAS REVISED TO A 20MM THICK ATTUNE CRS POLYETHYLENE INSERT. STIMULAN PELLETS WERE PLACED, AND THE WOUND CLOSED. THERE WERE NO COMPLICATIONS.

  Patient problems: Discomfort; Erythema; Fluid Discharge; Muscular Rigidity; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18579782 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE SEPSIS OF LEFT TOTAL KNEE ARTHROPLASTY : INFECTION - DEEP. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: SURGICAL I&D PERFORMED, WITH TIBIAL INSERT EXCHANGE AND ANTIBIOTIC PELLET PLACEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12480324 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12149489 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT HAD A BILATERAL CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS BILATERAL OSTEOARTHRITIS. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA WERE USED DURING THE PROCEDURE. ON (B)(6) 2017, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS ACUTE HEMATOGENOUS SEPSIS. THE RIGHT KNEE WAS ALSO ASPIRATED. PRIOR TO SURGERY, THE PATIENT WAS NOTED TO HAVE PAIN. THE PATIENT WAS NOTED TO HAVE HAD A PRIOR ASPIRATION AND WAS POSITIVE FOR INFECTION. ON (B)(6) 2021, THE PATIENT HAD A REVISION OF ALL COMPONENTS, LEFT TOTAL KNEE ARTHROPLASTY, TO ADDRESS CHRONIC INFECTION. THE TIBIAL INSERT WAS REVISED. PRIOR TO SURGERY THE PATIENT WAS NOTED TO HAVE PAIN, SWELLING, DISCOMFORT, EFFUSION, AND RECURRENT INFECTION. THE PATIENT IS HAVING A STAGE 1 REVISION FOR INFECTION NOW. ALL COMPONENTS WERE NOTED TO BE WELL FIXED PRIOR TO REMOVAL. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015. DATE OF REVISION #1: (B)(6) 2017 (INSERT). DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain; Swelling/ Edema

  MAUDE report 11871338 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY. THE SURGEON INDICATED RETAINED TIBIAL HARDWARE FROM PREVIOUS KNEE SURGERIES. THE MANUFACTURER OF THE HARDWARE IS UNKNOWN. ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT KNEE REVISION WITH TIBIAL INSERT EXCHANGE, IRRIGATION AND DEBRIDEMENT, AND PLACEMENT OF ANTIBIOTIC PELLET TO ADDRESS INFECTION. PRIOR TO REVISION, THE PATIENT WAS ALSO EXPERIENCING PAIN, DISCOMFORT, SWELLING, FEVER, EFFUSION, AND INSTABILITY. THE SURGEON NOTED THE PATIENT WOULD BE ON IV ANTIBIOTICS FOR 6 WEEKS FOLLOWING REVISION. ON (B)(6) 2020, THE PATIENT PRESENTED FOR A POST-OPERATIVE EVALUATION WITH SOME ESCHAR AROUND WOUND, MILD EFFUSION, AND SOME SWELLING IN THE LEG DOWN TO THE FOOT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fever; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11124627 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON WASHED THE KNEE OUT AND OUT IN ANTIBIOTIC BEADS AND DECIDED TO SWAP OUT THE POLY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11123583 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS DUE TO INFECTION. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11120021 ↗
• InjuryJan 5, 2021Unintended Movement; Unintended Movement

  THE PATIENT WAS REVISED TO ADDRESS A SPIN-OUT OF THE POLY. A REPLACEMENT WITH A THICKER POLY WAS DONE ON (B)(6) 2020. THE SURGEON WANTED TO PUT A MORE STABLE CONSTRUCT IN. DOI: (B)(6) 2020, DOI: (B)(6) 2020 (INSERT), DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11116791 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2012 INDICATED THAT THE PATIENT RECEIVED A BILATERAL TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES (B)(6) 2020 INDICATED THAT THE PATIENT WAS SEEN AS FOR FOLLOW-UP OF THE RIGHT KNEE. AROUND 5 MONTHS AGO, THE PATIENT EXPERIENCED A SIGNIFICANT HEMARTHROSIS WHICH RESULTED IN ASPIRATION AND DISCONTINUATION OF THE BLOOD THINNER. THE PATIENT WAS STILL EXPERIENCING MILD MID-FLEXION INSTABILITY, AS WELL AS MILD PAIN, SWELLING, STIFFNESS AND POSSIBLE CONTINUED HEMARTHROSIS. TREATMENT AT THIS TIME IS CONTINUED OBSERVATION.

  Patient problems: Joint Laxity; Muscular Rigidity; No Code Available; Pain; Swelling/ Edema

  MAUDE report 10872489 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY, BOTH THE FEMORAL AND TIBIAL COMPONENTS TO ADDRESS ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND RECURRENT HEMARTHROSIS. DEPUY COMPONENTS INCLUDING DEPUY CEMENT WERE USED DURING THIS PROCEDURE. FEMORAL COMPONENT WAS NOTED TO BE LOOSE, BUT NO INTERFACE OF LOOSENING PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10286074 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10102697 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

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

  Patient problems: Damage to Ligament(s); Edema; Inflammation; No Code Available; Not Applicable; Unspecified Infection

  MAUDE report 7464272 ↗
• InjuryApr 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. IT WAS ALSO INDICATED THAT THE SURGEON DECIDED IT IS BEST TO WASHOUT THE KNEE JOINT AND REPLACE THE POLY INSERT. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE. NO SURGICAL DELAY.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7453613 ↗
• InjuryApr 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. TREATMENT INCLUDES IRRIGATION AND DEBRIDEMENT AS WELL AS REVISION OF THE INSERT. DOI: (B)(6) 2018, DOE: (B)(6) 2018, DOR: (B)(6) 2018, (RIGHT KNEE).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7450159 ↗
• InjuryFeb 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR OSTEOLYSIS OF TIBIAL AND FEMORAL BONE. IT IS NOTED THE PATIENT IS ALSO EXPERIENCING INCREASING PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS PROBABLY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. REVISION DUE TO OSTEOLYSIS HAS OCCURRED. DOI: (B)(6) 2014. DOE: (B)(6) 2017. DOR:(B)(6) 2018. (LEFT KNEE).

  Patient problems: Osteolysis; Pain

  MAUDE report 7245609 ↗
• InjuryFeb 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN WITH STIFFNESS. DOI: (B)(6) 2014; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7240602 ↗
• InjuryJan 24, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT HAS INFECTION IN JOINT. I AND D WITH A POLY SWAP WAS PERFORMED. (B)(6) 2017 ; (B)(6) 2018 ; RIGHT KNEE.

  Patient problems: No Code Available; Renal Failure; Unspecified Infection

  MAUDE report 7215029 ↗