SIGMA AOX 1961-92-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295076087), received between Jan 14, 2020 and Sep 16, 2024 — classified as 19 injuries, 1 malfunction.

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS. IS THIS EVENT RELATED TO THE STUDY DEVICE? NOT RELATED. IS THIS EVENT RELATED TO THE STUDY PROCEDURE? REMOTE POSSIBILITY. DATE OF EVENT: 28/AUG/2024. ADDITIONAL EVENT INFORMATION: CLINIC NOTE AD 5 SEP 2024. ON 08/28/2024, MEDICAL RECORDS NOTE THE PATIENT IS FOUR YEARS POST RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT WAS NOTED TO HAVE ARTHROFIBROTIC KNEE WITH PAIN AND STIFFNESS. THE PATIENT HAD A SCAR TISSUE SURGERY WITH OPEN RESECTION, POLY SWAP IN THE PAST. THE PATIENT THEN FELL AND HAD REGRESSION AND RETURN OF ARTHROFIBROSIS. THE PATIENT HAS INCREASED PAIN, DIFFICULT TIME WITH MOBILITY. AN ASPIRATION OF KNEE WAS PERFORMED AND NEGATIVE FOR ANY TIME OF BACTERIAL INFECTION. THE SURGEON SUGGESTED TOTAL KNEE ARTHROPLASTY REVISION FOR ARTHROFIBROSIS.

  Patient problems: Adhesion(s); Fall; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 20223279 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION. DEVICE AND PROCEDURE (RELATEDNESS) INFORMATION NOT PROVIDED. DATE OF EVENT: INFORMATION NOT PROVIDED. DATE OF IMPLANT: INFORMATION NOT PROVIDED. DATE OF REVISION: (B)(6) 2024. DEVICE LOCATION: INFORMATION NOT PROVIDED. TREATMENT/IMPACT: DEPUY COMPONENTS REMOVED. ADDITIONAL EVENT INFORMATION: UPDATE: MEDICAL RECORDS RECEIVED ON AD (B)(6) 2024 WERE REVIEWED BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. DOR: (B)(6) 2024: 53-YEAR-OLD FEMALE PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN, SWELLING, JOINT INSTABILITY, AND DISCOMFORT. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED SCAR TISSUE AND SYNOVITIS AND CONFORMED JOINT INSTABILITY IN VARUS/VALGUS STRESS. THE FEMORAL COMPONENT, TIBIAL TRAY, AND PATELLA WERE ALL WELL-FIXED AND RETAINED. THE TIBIAL INSERT WAS REVISED TO A LARGER SIZE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. LEFT KNEE.

  Patient problems: Adhesion(s); Discomfort; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20089004 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD UNSTABLE KNEE. POLY WAS SWAPPED FROM 10MM TO 15MM. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19989996 ↗
• InjuryJun 6, 2024Naturally Worn; Naturally Worn

  THE PATIENT UNDERWENT REVISION DUE TO POLY EXCHANGE AS THE POSTERIOR AND LATERAL SIDE WAS WORN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN DOR:(B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19479917 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 17660881 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED A THICKER POLY. 10MM WAS EXPLANTED, 17.5 WAS IMPLANTED. DOI: (B)(6) 2019, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17487058 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: DOE: (B)(6) 2023: PATIENT REPORTS TO THE OFFICE WITH RIGHT KNEE PAIN, INSTABILITY, AND A POPPING SENSATION. THE PATIENT ALSO STATES THAT SHE HAS BEEN ON A NEW HEART MEDICATION THAT CAUSES HER TO FEEL DIZZY AND HAVE MULTIPLE FALLS. PHYSICAL EXAM CONFIRMS HYPEREXTENSION AND VARUS/VALGUS LAXITY. X-RAYS IDENTIFY A WELL-FIXED TKA WITH A VALGUS ALIGNMENT IF 2.5 DEGREES. THE SURGEON DIAGNOSES HER WITH GLOBAL INSTABILITY AND REFERRED HER TO HAVE THE INSERT REVISED. SURGERY WILL BE SCHEDULED AFTER THE PATIENT IS CLEARED BY HER CARDIOLOGIST. THERE WAS NO REVISION NOTED IN THE ATTACHED MEDICAL RECORDS.

  Patient problems: Dizziness; Fall; Joint Laxity; Pain

  MAUDE report 17317892 ↗
• InjuryJul 13, 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) 2018. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 17317855 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS CONFIRMED FOR INFECTION. A POLY SWAP AND DEBRIDEMENT WERE PERFORMED. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17310532 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION AND SEVERE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO EITHER DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND PATELLA WERE REMOVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17216874 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO CLUNK. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2022. LEFT KNEE. TREATMENT: REMOVAL OF INSERT.

  Patient problems: Adhesion(s); Joint Laxity; Pain; Unspecified Musculoskeletal problem

  MAUDE report 15163512 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECENTLY HAD A RIGHT TOTAL KNEE DONE, HAD FALLEN ONTO THAT RIGHT KNEE, RE-OPENING THE SURGICAL SITE. SURGEON PERFORMED A WASHOUT OF THE KNEE AND REPLACED THE TIBIAL INSERT. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 14141069 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT HAD AN EXCISION OF NODULAR FAT JUST ABOVE THE PREPATELLAR BURSA WITH REMOVAL OF MULTIPLE ETHIBOND SUTURES, RIGHT KNEE. THE BURSA HAD BECOME PAINFUL. THE SURGEON REPORTED FINDING NODULAR FATTY TISSUE JUST ABOVE THE PREPATELLAR BURSA, WHICH WAS CREATING SOMEWHAT OF A BAND ACROSS THE BURSA. THAT WAS THE MAIN ISSUE. THE SURGEON ALSO REMOVED MULTIPLE ETHIBOND SUTURES. DOI: (B)(6) 2016. DOE: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Inflammation; Pain

  MAUDE report 12211425 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR LEFT TOTAL KNEE REVISION TO ADDRESS STIFFNESS DATE OF IMPLANTATION: (B)(6) 2018. PRIOR TO LEFT KNEE REVISION ON (B)(6) 2021, THE PATIENT WAS ALSO EXPERIENCING FALLS, DECREASED RANGE OF MOTION, WALKING DIFFICULTY, ARTHROFIBROSIS, AND ADHESIONS. THE TIBIAL INSERT WAS THE ONLY PRODUCT REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Fall; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 11266041 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY OPERATIVE NOTE, MULTIPLE POST-OPERATIVE NOTES, AND REVISION OPERATIVE NOTE WERE REVIEWED. IN ADDITIONAL TO THE PREVIOUSLY ALLEGED PATIENT HARMS, THE PATIENT WAS ALSO EXPERIENCING DISCOMFORT AND INSTABILITY PRIOR TO REVISION. THE REVISION OPERATIVE NOTE ALSO INDICATED A SMALL AMOUNT OF EROSION JUST PROXIMAL TO THE FEMORAL FLANGE DISCOVERED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11243020 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  OFFICE NOTES (B)(6) 2021 INDICATED THAT THE PATIENT¿S RIGHT KNEE WAS DOING WELL. THE LEFT KNEE WAS NOTED TO HAVE FELT A LARGE POP WHILE GETTING BACK INTO BED. THE PATIENT FELT LIKE THE KNEE SHIFTED. THE PATIENT HAD TO MOVE THE KNEE AND THEN IT FELT BETTER, BUT IT WAS QUITE SWOLLEN. THE LEFT KNEE THAT WAS VERY SORE AND VERY UNSTABLE. PHYSICAL EXAM OF THE LEFT KNEE REVEALED GROSS INSTABILITY WITH PCL DYSFUNCTION AND DECREASED RANGE OF MOTION. RADIOGRAPHIC IMPRESSION: STABLE KNEE ARTHROPLASTY ON THE RIGHT. QUESTION POLY SPINOUT AND THE POLY 180 DEGREES FROM OPTIMAL POSITION LEFT KNEE. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATED THAT THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO GLOBAL INSTABILITY, SWELLING, MCL INSUFFICIENCY, PCL RUPTURE, SPINOUT OF THE TIBIAL BEARING 180 DEGREES AND TIBIAL-FEMORAL SUBLUXATION. INSERT AND FEMORAL COMPONENT REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 11231214 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED INDICATED THAT ON (B)(6) 2016, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS, END-STAGE, BILATERAL KNEES. DURING THE PROCEDURE THE SURGEON NOTED THAT BOTH PATELLAS HAD SIGNIFICANT EROSION OF THE LATERAL PATELLAR FACET. THE SURGEON DECIDED TO CUT THE PATELLA DOWN TO 12 MM, AND NOT GO ANY THINNER. THAT LEFT A DEFECT IN THE LATERAL FACET OF BOTH PATELLAS, WHICH WAS FILLED IN WITH CEMENT. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE. ON (B)(6) 2019, THE PATIENT HAD AN EXCISION OF NODULAR FAT JUST ABOVE THE PREPATELLAR BURSA WITH REMOVAL OF MULTIPLE ETHIBOND SUTURES, RIGHT KNEE. THE BURSA HAD BECOME PAINFUL. THE SURGEON REPORTED FINDING NODULAR FATTY TISSUE JUST ABOVE THE PREPATELLAR BURSA, WHICH WAS CREATING SOMEWHAT OF A BAND ACROSS THE BURSA. THAT WAS THE MAIN ISSUE. THE SURGEON ALSO REMOVED MULTIPLE ETHIBOND SUTURES. ON (B)(6) 2020, THE PATIENT HAD A REVISION, RIGHT TOTAL KNEE ARTHROPLASTY, TO ADDRESS FAILED RIGHT TOTAL KNEE ARTHROPLASTY, FEMORAL COMPONENT LOOSENING. THE INDICATIONS FOR SURGERY INCLUDED: PAIN, DISCOMFORT, AND STIFFNESS. DURING THE PROCEDURE THE SURGEON REPORTED THAT THE FEMORAL COMPONENT AS WELL AS THE PATELLA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Muscular Rigidity; Osteolysis; Pain; Synovitis

  MAUDE report 11178806 ↗
• InjuryApr 24, 2020Adverse 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 SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015. DATE OF EVENT (ONSET): (B)(6) 2019; (LEFT KNEE).

  Patient problems: No Code Available

  MAUDE report 9996520 ↗
• MalfunctionJan 28, 2020Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  UPDATE: ON (B)(6) 2020. MEDICAL RECORDS WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY AND SYNOVITIS. THE SURGEON NOTED MINIMAL TIBIAL INSERT WEAR. THE TIBIAL INSERT WAS THE ONLY COMPONENT REVISED. THE TIBIAL TRAY, FEMORAL COMPONENT, AND PATELLAR COMPONENT WERE WELL-FIXED AND RETAINED. DOI: ON (B)(6) 2015. DOR: ON (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Synovitis

  MAUDE report 9637423 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE SURGEON DECIDED TO INCREASE THE POLY SIZE FOR STABILITY. NO FURTHER INFORMATION WAS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2019, UNKNOWN KNEE SIDE.

  Patient problems: No Code Available

  MAUDE report 9586522 ↗