SIGMA AOX 1961-92-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295076124), received between Oct 25, 2017 and May 14, 2024 — classified as 28 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 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 DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024 DATE OF REVISION: (B)(6) 2024 DATE OF EVENT: 25 APR 2024 (RIGHT KNEE) TREATMENT: I&D AND REVISION; INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 19313045 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL SEVERAL MONTHS AGO AND WAS NOT CONFIRMED FOR INFECTION. THERE WAS NO DELAY OR BROKEN INSTRUMENTS IN THE CASE. THE KNEE WAS WASHED OUT AND AN POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 19278860 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: 25 APR 2024. (RIGHT KNEE). TREATMENT: I&D.

  Patient problems: Unspecified Infection

  MAUDE report 19228716 ↗
• InjuryApr 18, 2024Adverse 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 CR CONSTRUCT IN (B)(6) 2021. SHE HAS DEVELOPED PAIN OVER THE YEARS SINCE THE KNEE. SHE DEVELOPED POOR PATELLAR TRACKING IN THIS KNEE. A TIBIA TUBERCLE OSTEOTOMY WAS PERFORMED TO HELP WITH PATELLAR TRACKING AND KNEE REVISION WAS PERFORMED. THE FEMUR, INSERT, AND TIBIA WERE ALL REMOVED AND AN ATTUNE CRS REVISION CONSTRUCT WAS PLACED. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19135159 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: 29 FEB 2024. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL, TIBIAL, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 18874201 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS . EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6). 2023. DATE OF EVENT: (B)(6). 2023. (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Muscular Rigidity

  MAUDE report 18160056 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE) . TREATMENT: INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 18119425 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. POLY WAS SWAPPED FROM 10MM TO 17.5MM. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18063863 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO LOOSENING. PATIENT WAS REVISED TO A THICKER INSERT FOR STABILITY. DOI: (B)(6) 2017, DOR: (B)(6) 2023, AFFECTED SIDE : LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16786961 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TKA ON 2005. THE PATIENT HAD DONE WELL WITH THE KNEE UNTIL DEVELOPING AN INFECTION. PATIENT WAS WASHED OUT AND POLY WAS EXCHANGED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2005. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16101668 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. POLY EXCHANGE WAS PERFORMED. WENT FROM A 10 MM INSERT TO A 12.5 THICKNESS TO CREATE MORE JOINT STABILITY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15744545 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION AND PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022; (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REMOVED.

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

  MAUDE report 15249320 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OFFICE NOTE (B)(6) 2022 INDICATE THE PATIENT HAD BEEN EXPERIENCING SOME POST OPERATIVE WOUND BLEEDING AND DRAINAGE WITH SLIGHT SKIN EXCORIATION AND NECROSIS THAT HAD BEEN TREATED WITH A WOUND VAC. THE WOUND DOES SHOW SIGNS ON IMPROVEMENT IN OFFICE. SHE IS ON IV ANTIBIOTICS AND THE WOUND VAC WAS EXCHANGED. SHE IS ALSO IN A KNEE IMMOBILIZER FOR THE TIME BEING.

  Patient problems: Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Necrosis; Pocket Erosion; Swelling/ Edema

  MAUDE report 15216507 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY AND IT BAND SNAPPING. DATE OF IMPLANT: (B)(6) 2021, DATE OF REVISION: (B)(6) 2022, (LEFT KNEE). REVISION OF THE TIBIAL INSERT ONLY WITH IT BAND RELEASE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 14487698 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2003, DOE: (B)(6) 2022, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13452951 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASING PAIN AND SWELLING. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DOI: (B)(6) 2012; DOE: UNK (RIGHT KNEE ASPIRATIONS); DOR: (B)(6) 2021; (RIGHT KNEE).

  Patient problems: Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 13282880 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE PATIENT RECEIVED A RIGHT KNEE INSERT REVISION TO TREAT PAIN, STIFFNESS, SWELLING, AND MILD INSTABILITY. UPON ENTERING THE JOINT THE SURGEON EVACUATED JOINT EFFUSION AND TREATED EXTENSIVE SYNOVITIS WITH A COMPLETE SYNOVECTOMY. THE SURGEON NOTES THAT ALL COMPONENTS WERE WELL-FIXED WITH NO SIGN OF LOOSENING. A LARGE 7-8 MM OSTEOPHYTE WAS REMOVED FROM THE POSTERIOR FEMUR AND A SMALL BONE OVERGROWTH WAS REMOVED FROM THE PATELLA. THE SURGEON EXCISED SOME AREAS OF HYPERTROPHIC BONE FROM THE TIBIA. THE SURGEON NOTES THAT THE SYNOVITIS AND HYPERTROPHIC BONE WERE SECONDARY TO THE INFLAMMATION CAUSED BY THE IRRITATION CAUSED BY THE LARGE FEMORAL OSTEOPHYTE. THE FEMORAL COMPONENT, TIBIAL TRAY, AND PATELLA WERE RETAINED. THE TIBIAL TRAY WAS REVISED WITH DEPUY AOX CR INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. REVIEW OF THE CLINICAL DATABASE CONFIRM THAT THE REVISION WAS PERFORMED ON THE RIGHT KNEE. DOI: (B)(6) 2021. DOE: UNK (RIGHT KNEE ASPIRATIONS). DOR: (B)(6) 2021 (INSERT EXCHANGE).

  Patient problems: Inflammation; Joint Laxity; Muscular Rigidity; Pain; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 13102136 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASSOCIATED STUDY: ROTATING PLATFORM, ROTATING PLATFORM DATE OF EVALUATION: 9/FEB/2015 DATE OF ONSET: (B)(6) 2021 OPERATIVE SIDE: LEFT. DIAGNOSIS: ADHESIONS LT TKA. ADVERSE EVENT: ADHESIONS. ON (B)(6) 2021, THE PATIENT HAD A LEFT HYBRID TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE, LEFT KNEE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE USED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A CLOSED MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS, STATUS POST LEFT TOTAL KNEE ARTHROPLASTY.

  Patient problems: Adhesion(s)

  MAUDE report 12467343 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS EVENT IS SERIOUS AND IS CONSIDERED MODERATE THERE IS A REMOTE POSSIBILITY EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS, END-STAGE, RIGHT KNEE. THE SURGEON REPORTED THAT THE PATIENT HAD A VERY TIGHT EXTENSOR MECHANISM THAT WHEN THE KNEE WAS INITIALLY FLEXED THERE WAS A ¿LITTLE BIT OF PEEL OF THE (PATELLA) TENDON¿. ANCHORS WERE PLACED AND SUTURES WERE USED TO ANCHOR THE TENDON IN REPAIR. (B)(6) 2021 NOTED THAT THE PATIENT¿S PATELLA TENDON HAD PEELED OFF QUITE SIGNIFICANTLY DURING THE SURGERY, WHICH IS WHY SHE IS ON RESTRICTED FLEXION. ON (B)(6) 2021, THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS OF THE RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS STIFFNESS DATE OF IMPLANTATION: (B)(6) 2021 DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA.

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

  MAUDE report 12277811 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. IN ADDITION TO THE PREVIOUS ISSUE OF IT BAND CROSSOVER PAIN, DURING THE EVALUATION AND INJECTION OF MEDICATION ON (B)(6) 2021, THE PATIENT WAS ALSO EXPERIENCING DISCOMFORT AND DIFFICULTY WALKING.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain

  MAUDE report 11629590 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS : ADHESIONS EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF EVENT (ONSET): (B)(6) 2015 (RIGHT KNEE). TREATMENT: SURGICAL INTERVENTION - CLOSED MANIPULATION OF THE KNEE UNDER ANESTHESIA.

  Patient problems: Adhesion(s)

  MAUDE report 11594389 ↗
• InjuryJun 29, 2020Adverse 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 INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF REVISION: (B)(6) 2020, (LEFT KNEE). TREATMENT: TIBIAL INSERT WAS REVISED.

  Patient problems: Fall; No Code Available; Pain

  MAUDE report 10207105 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2018; DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9660877 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8901575 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE DOCTOR REPLACED THE INSERT AND WASHED OUT THE JOINT. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8780606 ↗