SIGMA AOX 1961-92-041Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295076209), received between Apr 25, 2019 and Mar 4, 2025 — classified as 31 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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 31 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED IT BAND AND SCAR TISSUE RELEASE. POLY WAS SWAPPED FOR SAME SIZE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 21514683 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INSTABILITY. POLY WAS SWAPPED FROM 10 TO 15MM. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21066274 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18055169 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16843735 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY AND INCREASE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021; DATE OF REVISION: UNK; DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 16095709 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS AND HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2015. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: ASPIRATION OF 10ML OF BLOODY FLUID, SENT FOR SYNOVASURE.

  Patient problems: Fall; Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 16014650 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE PAIN. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15191949 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE,LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13693241 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B(6) 2017; DATE OF REVISION: (B)(6) 2022; (RIGHT KNEE). TREATMENT: REVISION OF FEMUR, TIBIAL TRAY, INSERT, AND PATELLA.

  Patient problems: Unspecified Infection

  MAUDE report 13653341 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS REVIEWED INDICATED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH TIBIAL INSERT EXCHANGE, IRRIGATION AND DEBRIDEMENT, AND PLACEMENT OF ANTIBIOTIC-CONTAINING PELLETS TO ADDRESS INFECTION. LEADING UP TO REVISION THE PATIENT WAS EXPERIENCING PAIN, SWELLING, INSTABILITY, WARMTH AND REDNESS OF KNEE, DIFFICULTY WALKING, DECREASED RANGE OF MOTION, STIFFNESS, AND RASH LATERAL TO INCISION. THE RETAINED COMPONENTS WERE ALL WELL-FIXED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Ambulation or Postural Difficulties; Erythema; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain; Rash; Swelling/ Edema; Unspecified Infection

  MAUDE report 12860595 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INFECTION. AN I&D AND POLY SWAP WAS PERFORMED. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12827506 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE REVISION DUE TO INFECTION. ALL IMPLANTS REMOVED. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12640795 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISTAL INCISIONAL WOUND, SUPERFICIAL VS DEEP EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017. DATE OF REVISION: (B)(6) 2021 (ADDRESSED IN (B)(4)). DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: DEBRIDMENT OF DEVASCULARIZED TISSUE AND SMALL SUTURE REMOVED. CLEANSED WITH PEROXIDE, THE PT IS ALREADY ON ANTIBIOTICS.

  Patient problems: Wound Dehiscence

  MAUDE report 12586512 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS REVIEWED AND INDICATED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY PRODUCTS AND CEMENT WERE USED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS INFECTION, PAIN, SWELLING, ERYTHEMA, AND STIFFNESS. THE SURGEON IDENTIFIED THE ISSUE AS ACUTE HEMATOGENOUS SEPSIS. THE SURGEON REVISED THE TIBIAL INSERT, PERFORMED AN IRRIGATION AND DEBRIDEMENT, AND PLACED ANTIBIOTIC PELLETS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

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

  MAUDE report 12529323 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AND OPERATIVE NOTES REVIEWED: ON (B)(6) 2021, PATIENT RECEIVED A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS END-STAGE OSTEOARTHRITIS. THE PATIENT RECEIVED J&J SIGMA PRESS-FIT FEMUR AND CEMENTED PATELLA AND TIBIAL TRAY COMPONENTS, WITH CR RP TIBIAL INSERT ARTICULATION. DEPUY BONE CEMENT WAS UTILIZED. THE PROCEDURE HAD NO REPORTED COMPLICATIONS. ON (B)(6) 2021, PATIENT WAS TREATED WITH A LEFT KNEE MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS. PRIOR TO THE PROCEDURE, HE ONLY HAD ABOUT 95 DEGREES OF FLEXION, WITH SIGNIFICANT STIFFNESS. FOLLOWING THE MANIPULATION, THE PATIENT WAS ABLE TO FLEX BETWEEN 115-120 DEGREES. THERE WERE NO REPORTED COMPLICATIONS.

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

  MAUDE report 12481518 ↗
• InjurySep 15, 2021Unintended Movement; Unintended Movement

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS FALL AND HAD BEARING SPIN OUT. REPLACED WITH THICKER BEARING. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 12477113 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR EXPRACAPSULAR DRAINAGE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. 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: PLACEMENT IN KNEE IMMOBILIZER AND RECHECK WOUND IN TWO DAYS. ON (B)(6) 2021 THE PATIENT HAD A LEFT HYBRID TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA, ALONG WITH DEPUY CEMENT WERE USED DURING THIS PROCEDURE. ON (B)(6) 2021 PATIENT WAS ADMITTED TO HOSPITAL FOR SEPSIS, WHICH THE SURGEON NOTED THAT ¿THEY THINK IS COMING FROM HER GALLBLADDER¿.

  Patient problems: Fluid Discharge; Sepsis

  MAUDE report 12200581 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN IN HER LEFT KNEE. UPON OPENING THE JOINT SURGEON TOOK SOME TISSUE SAMPLES TO CHECK FOR INFECTION. SURGEON DECIDED IT BEST TO REMOVE THE POLY AND GO UP TO A 15MM. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2018; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12196369 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN ERROR BY THE SURGEON, THE PATIENT NEEDED A THICKER INSERT. DOI: (B)(6) 2016; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12142317 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AFTER THE FIRST SURGERY AND TORE A LIGAMENT. THE SURGEON CONVERTED THE FEMUR AND INSERT TO A PS COMPONENT. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 11863575 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2021: CLINICAL POST-OP VISIT, BILATERAL KNEE REPLACEMENTS: SEEN BY PHYSICIAN'S ASSISTANT IN OFFICE. PATIENT PRESENTED WITH FEELING OF "GIVING OUT" AND "TAPPING" IN KNEES. IN PHYSICAL EXAMINATION, THE RIGHT KNEE DEMONSTRATED 2MM OF VARUS AND VALGUS LAXITY, WHICH SUGGESTED GLOBAL INSTABILITY. THE RIGHT KNEE WAS CAPTURED IN (B)(4). THE LEFT KNEE WAS DETERMINED TO HAVE QUADRICEPS WEAKNESS, REQUIRING PHYSICAL THERAPY ONLY. PLAN WAS FOR PHYSICAL THERAPY ON BOTH KNEES, AND TO HAVE PATIENT RETURN TO BE SEEN BY ATTENDING PHYSICIAN, AND DISCUSS POSSIBLE RIGHT KNEE REVISION TO INCREASE THICKNESS OF THE TIBIAL INSERT. DOI: (B)(6) 2020 DATE OF EVENT (ONSET): (B)(6) 2021 LEFT KNEE.

  Patient problems: Fatigue; Joint Laxity

  MAUDE report 11753475 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT DISCOMFORT IN BOTH KNEES. POSTERIOR STIFFNESS AND PAIN. PAIN IS BILATERAL BUT WORSE IN THE LEFT. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2021; (LEFT KNEE). TREATMENT: LEFT KNEE WAS ASPIRATED AND SENT FOR SYNVASURE TO RULE OUT INFECTION. NO ARTHROFIBROSIS NOTED. LEFT KNEE IS STABLE. NO TREATMENT REPORTED FOR THE RIGHT SIDE.

  Patient problems: Discomfort; Muscular Rigidity; Pain

  MAUDE report 11334339 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INSTABILITY DATE OF IMPLANTATION: (B)(6) 2020. DATE OF REVISION: (B)(6) 2020 (LEFT KNEE). TREATMENT: REVISION OF FEMUR AND TIBIAL INSERT COMPONENTS; TIBIAL TRAY AND PATELLA WERE RETAINED

  Patient problems: No Code Available

  MAUDE report 10791946 ↗
• InjuryOct 2, 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: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10621729 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STIFFNESS. THE PATIENT UNDERWENT A SIGMA RP CVD CONSTRUCT SEVERAL YEARS AGO. ACCORDING TO THE PATIENT, HE'S NEVER DONE WELL WITH HIS RIGHT KNEE. HIS RIGHT KNEE HAS BEEN FAIRLY STIFF SINCE HIS SURGERY IN 2017. SURGEON ELECTED TO REMOVE THE FEMUR, INSERT, AND TIBIA AND PROCEED WITH A REVISION CONSTRUCT TO RELIEVE SOME OF THE STIFFNESS AND HELP THE PATIENT REGAIN MOTION. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2017; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available

  MAUDE report 10609631 ↗