SIGMA AOX 1961-92-051Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295076247), received between Dec 13, 2018 and Jun 24, 2026 — classified as 22 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BTK (B)(6) 2023, LEFT KNEE BECAME UNSTABLE, NO PROBLEMS W IMPLANTS/CEMENT, JUST GENERAL INSTABILITY, FIXED TODAY BY EXCHANGING 10MM POLY TO 15 MM POLY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25611146 ↗
• InjuryMar 26, 2026Naturally Worn

  IT WAS REPORTED THAT PATIENT HAD KNEE DISCOMFORT. POLY WAS WORN POSTERIOR LATERAL. PATELLA AND POLY WERE EXCHANGED. POLY WENT FROM 5 X 10 TO 5 X 12.5. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Discomfort

  MAUDE report 24702071 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SHOWING SIGNS OF INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22907408 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TIBIA/PATELLA/POLY REVISION DUE TO PAIN. CEMENT MANTLE OF TIBIA DIDN'T APPEAR NORMAL ON X-RAY. PATELLA HAD DELAMINATED. MBT REVISION TIBIA WITH 13X90 STEM WAS PUT IN WITH A 5X12.5 REP CVD POLY AND A 38 PATELLA. DOI: (B)(6) 2016 DOR: (B)(6) 2024 AFFECTED SIDE RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20777136 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. A. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE?- -DON¿T KNOW THE ORIGINAL SURGERY DATE - ABOUT 14 YEARS AGO B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? - NO DELAYS.

  Patient problems: Pain

  MAUDE report 17563271 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AFTER TKA AND UNDERWENT POLY EXCHANGE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17441519 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2023, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS ENDSTAGE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT, WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2023, THE PATIENT WAS REVISED TO ADDRESS ACUTE SEPSIS. THE PATIENT HAD A FALL, THE WOUND DEHISCED A LITTLE BIT SUPERFICIALLY, THEN DEVELOPED A DEEP INFECTION. THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE. ON (B)(6) 2023, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY, IRRIGATION, AND DEBRIDEMENT TO ADDRESS PERSISTENT INFECTION. DURING THE PROCEDURE, THE TIBIAL INSERT WAS REMOVED AND A NEW DEPUY INSERT WAS PLACED. THE SURGEON OBSERVED THAT THE MEDIAL THIRD OF THE PATELLAR TENDON APPEARED SOMEWHAT AVASCULAR, NOT NECESSARILY NECROTIC, JUST AVASCULAR.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17390450 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: DOI: (B)(6) 2014: PATIENT RECEIVED BILATERAL SIGMA TKAS TO TREAT OSTEOARTHRITIS. BILATERAL PATELLAS WERE RESURFACED AND UNKNOWN CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOE: (B)(6) 2023: PATIENT PRESENTS TO CLINIC WITH EFFUSION, PAIN, GRINDING SENSATIONS, WALKING DIFFICULTY, AND CREPITUS OF THE LEFT KNEE. PHYSICAL EXAM IDENTIFIES 1 MM LAXITY AND CONFIRMS WALKING DIFFICULTY, EFFUSION, AND SYNOVITIS. X-RAYS IDENTIFY A STABLE KNEE WITH A VERY THIN LUCENCY UNDER THE ANTERIOR FLANGE. THE PATIENT IS REFERRED FOR EXPLORATORY SURGERY TO IDENTIFY THE SOURCE OF THE SYNOVITIS AND CREPITUS. THERE WERE NO INDICATIONS THAT THE PROCEDURE HAS BEEN COMPLETED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 17351085 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RECURRENT HEMARTHROSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT:(B)(6) 2014. DATE OF REVISION: UNK. DATE OF EVENT:(B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; REVISED COMPONENTS NOT SPECIFIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Pain; Swelling/ Edema; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 17154404 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A DRAINING WOUND. I&D WITH POLY EXCHANGE WAS DONE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 16132570 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RUPTURE OF MEDIAL ARTHROTOMY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: SURGICAL INCISIONAL REPAIR OF ARTHROTOMY WOUND DEHISCENCE.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 15690682 ↗
• InjuryJul 28, 2022Adverse 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 INCREASED SWELLING/ LARGE EFFUSION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2014. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: ASPIRATION/DRAINAGE (SENT FOR SYNOVASURE).

  Patient problems: Swelling/ Edema

  MAUDE report 15121632 ↗
• InjuryNov 23, 2021Noise, Audible; Noise, Audible

  (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS FLEXION INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: TIBIAL INSERT REVISED.

  Patient problems: Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 12859742 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO FELL AND OPENED INCISION. I&D POLY EXCHANGE PERFORMED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 12673850 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT A PRIMARY BILATERAL KNEE ARTHROPLASTY. DEPUY PRODUCTS WERE USED FOR EACH KNEE. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A LEFT KNEE EVALUATION DUE TO HEMARTHROSIS, EFFUSION, SWELLING, DISCOMFORT, AND DECREASED RANGE OF MOTION. A LEFT KNEE ARTHROCENTESIS WAS PERFORMED AND 60 ML OF BLOODY SYNOVIAL FLUID WAS REMOVED. IV ANTIBIOTICS WERE ALSO ADMINISTERED. THERE WERE NO INDICATED COMPLICATIONS.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 12525741 ↗
• InjurySep 14, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT CAME IN FEELING DISCOMFORT IN HIS RIGHT KNEE. THE SURGEON DECIDED IT BEST TO CHECK IT OUT. ONCE THE JOINT WAS OPENED HE DISCOVERED WEAR ON THE PATELLA AND BACKSIDE OF THE POLY. HE INCREASED THE POLY THICKNESS AND REPLACED THE PATELLA IMPLANT. NO INFORMATION COULD BE FOUND ON WHEN THE PROCEDURE WAS PERFORMED BESIDES 2009. DOI: 2009, DOR: (B)(6) 2021, (RIGHT KNEE).

  Patient problems: Discomfort

  MAUDE report 12467483 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISM. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2021; (LEFT KNEE). TREATMENT: INJECTED MEDICATION (UNSPECIFIED). CATALOG ID: 960103, LOT ID: 9610266, DESCRIPTION: SIGMA PATELLA OVAL DOME 3 PEGGED 41MM. CATALOG ID: 129433150, LOT ID: 9620470, DESCRIPTION: MBT CEMENTED KEEL SZ 5. CATALOG ID: 960005, LOT ID: D20021128, DESCRIPTION: SIGMA FEM C/RET CEMENTED LT SZ 5. CATALOG ID: 196192051, LOT ID: 9179151. DESCRIPTION: AOX CVD RP TIBIAL INSERT SZ 5 10MM. CATALOG ID: 3312040, LOT ID: 9322596, DESCRIPTION: SMART SET CMW 1 40G. CATALOG ID: 3312040, LOT ID: 9322596, DESCRIPTION: SMART SET CMW 1 40G.

  Patient problems: Pulmonary Embolism

  MAUDE report 11350685 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISM. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: INJECTED MEDICATION (UNSPECIFIED).

  Patient problems: Pulmonary Embolism

  MAUDE report 11346898 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND DEHISCENCE OF INCISION; FALL RESULTING IN OPENING OF HIS SURGICAL INCISION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. 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) 2020, (LEFT KNEE). TREATMENT: SURGICAL INTERVENTION WITH IRRIGATION AND DEBRIDEMENT.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 10269227 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ILEUS, GASTROINTESTINAL: HOSPITALIZED 4-5-WEEKS COLECTOMY AND ILEOSTOMY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2019; (RIGHT KNEE).

  Patient problems: No Code Available

  MAUDE report 9623706 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8424562 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY AND PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8159756 ↗