SIGMA AOX 1961-92-031Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295076162), received between Oct 18, 2017 and Oct 30, 2025 — classified as 39 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2025Adverse 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 INFECTED KNEE. IMPLANTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23423496 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN IN KNEE. POLY WAS SWAPPED FROM 10 TO A 12.5. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21161616 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR SPIN OUT. DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: NOT RELATED. DATE OF EVENT: 13/AUG/2024. DEVICE LOCATION: LEFT ADDITIONAL EVENT INFORMATION: ON 08/29/2024 MEDICAL RECORDS NOTE THE PATIENT HAS A HISTORY OF KNEE PAIN IN THE PATELLOFEMORAL LIGAMENT MEDIAL TO THE PATELLA. A SMALL BAND OF SCAR TISSUE IS PALPABLE. RADIOGRAPHS NOTE A WELL -PLACED ROTATING PLATFORM KNEE. THE SURGEON IMPRESSION IS OF A FIBROUS BAND OF TISSUE THAT IS BOTHERING THE PATIENT. THE SURGEON INJECTED THE KNEE WITH DEXAMETHASONE AND LIDOCAINE TO ADDRESS PAIN.

  Patient problems: Adhesion(s); Fibrosis; Pain

  MAUDE report 20232748 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. ASSOCIATED STUDY: ROTATING PLATFORM, ROTATING PLATFORM DATE OF EVALUATION: (B)(6) 2024. DATE OF ONSET: (B)(6) 2024 OPERATIVE SIDE: RIGHT. DIAGNOSIS: CHRONIC INFECTION. ADVERSE EVENT: INFECTION - DEEP. SPECIFY: COUNTRY: US. SERIOUS: YES. DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: REMOTE POSSIBILITY. ADDITIONAL EVENT INFORMATION: ON (B)(6) 2021, THE PATIENT WAS NOTED TO HAVE HAD A RIGHT TOTAL KNEE ARTHROPLASTY. ON (B)(6) 2022, THE PATIENT WAS NOTED TO HAVE FALLEN AND SUSTAINED A DISTAL FEMUR FRACTURE AND UNDERWENT ORIF OF THE DISTAL FEMUR FRACTURE. ON (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT HAD RIGHT KNEE PAIN, STATUS POST TOTAL KNEE REPLACEMENT AND SUBSEQUENT ORIF OF DISTAL FEMUR FRACTURE. IT WAS NOTED THAT THE PATIENT CONTINUES TO HAVE INTERMITTENT CELLULITIS SINCE THE ORIF ON (B)(6) 2022. IT WAS NOTE THAT THE PATIENT HAD INTERMITTENT CELLULITIS. THE KNEE HAD BE ASPIRATED (B)(6) 2023, WHICH SHOWED A STAPH EPIDERMIDIS INFECTION. RADIOLOGICAL REPORT NOTES THE PATIENT HAS A RIGHT TOTAL KNEE ARTHROPLASTY WITH SUBSIDENCE AND LOOSENING OF THE FEMORAL COMPONENT. THE RIGHT KNEE WAS NOTED TO HAVE CHRONIC INFECTION.

  Patient problems: Cellulitis; Pain; Unspecified Infection

  MAUDE report 19709643 ↗
• InjuryJun 5, 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 PULMONARY EMBOLISMS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. 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: ORAL MEDICATION AND CLOT REMOVALS.

  Patient problems: Pulmonary Embolism

  MAUDE report 19468609 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: 007-16301. STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISMS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: ORAL MEDICATION AND CLOT REMOVALS.

  Patient problems: Pulmonary Embolism

  MAUDE report 19463337 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  JUNE 2022: PATIENT RECEIVED A RIGHT KNEE I&D AND PRIMARY POLY SWAP TO TREAT HEMATOGENOUS SEPSIS. THE PATIENT WAS REVISED WITH AN UNKNOWN INSERT. THIS EVENT WAS NOTED AS PART OF THE PATIENT¿S MEDICAL HISTORY

  Patient problems: Sepsis

  MAUDE report 19157640 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR GI BLEED. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: (B)(6) 2024. (RIGHT KNEE). TREATMENT: FOUR UNITS OF BLOOD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19142596 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTE AD 18 OCT 2024 WAS REVIEWED BY CLINICIAN. ON (B)(6) 2024, THE PATIENT HAD A RIGHT TOTAL KNEE REVISION/REIMPLANTATION OF KNEE ARTHROPLASTY. A ZIMMER BIOMET FINN HINGED KNEE WAS UTILIZED. PATIENT HAD THEIR PREVIOUS TOTAL KNEE EXPLANTED THREE MONTHS PRIOR DUE TO CHRONIC SEPSIS. *NO MORE SPECIFIC DETAILS ON PREVIOUS IMPLANTS PROVIDED IN THE NEW MEDICAL RECORDS.

  Patient problems: Adhesion(s); Discomfort; Pain; Sepsis; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18941415 ↗
• InjuryFeb 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 FOOT DROP. 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: PATIENT FITTED WITH AFO.

  Patient problems: Nerve Damage

  MAUDE report 18703511 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION, DOCTOR PULLED THE IMPLANTS AND PUT IN A SPACER. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18379918 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISMS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: ORAL MEDICATION (ELIQUIS), CLOT REMOVALS. DEPUY PRODUCTS USED (NO REVISION COMPLETED):

  Patient problems: Pulmonary Embolism

  MAUDE report 17995266 ↗
• InjuryMar 29, 2023Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO INSERT WEAR AND LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. FEMALE PATIENT WAS MORBIDLY OBESE. DOI: (B)(6) 2011. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16635659 ↗
• InjuryNov 17, 2022Adverse 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) 2022. DATE OF REVISION: (B)(6) 2022. (LEFT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 15813940 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION FOR INSTABILITY. DATE OF IMPLANT: (B)(6) 2021; DATE OF REVISION: (B)(6) 2022; (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REMOVED.

  Patient problems: Joint Laxity; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15595057 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. INSERT WAS REMOVED. DATE OF IMPLANT:(B)(6) 2019. DATE OF REVISION: (B)(6) 2022. (RIGHT AND LEFT SIDE).

  Patient problems: Joint Laxity

  MAUDE report 14742876 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CONTINUED WOUND DRAINAGE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021; DATE OF EVENT: (B)(6) 2022 (RIGHT KNEE). TREATMENT: WOUND VAC PLACEMENT.

  Patient problems: Fluid Discharge

  MAUDE report 14437162 ↗
• InjuryApr 27, 2022Adverse 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) 2022, (LEFT KNEE). REVISION OF THE TIBIAL INSERT.

  Patient problems: Joint Laxity

  MAUDE report 14219119 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFLAMMATORY RESPONSE, POSSIBLE INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022 (LEFT KNEE). TREATMENT: ASPIRATION OF 30CC OF SEROSANGUINEOUS FLUID SENT FOR AEROBIC AND ANAEROBIC CULTURES, SYNOVIAL FLUID ANALYSIS.

  Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 14212384 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BROKEN WIRE AND THIS IS INCREASINGLY CAUSING PAIN. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021; DATE OF EVENT: (B)(6) 2022; (RIGHT KNEE). TREATMENT: A SURGICAL REMOVAL OF TENSION BAND WIRE, EXCISION OF NONHEALING WOUND, 7 CM WITH A PRIMARY SUTURE REPAIR AND PLACEMENT OF A LONG LEG CAST.

  Patient problems: Impaired Healing; Pain; Unspecified Tissue Injury

  MAUDE report 13860915 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR OCCASIONAL PAIN, POSSIBLE SYNOVIAL PINCHING OR REGROWTH OF FAT PAD. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: ARTHROSCOPY.

  Patient problems: Pain

  MAUDE report 13824048 ↗
• InjuryNov 23, 2021Noise, Audible; Noise, Audible

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR GLOBAL INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 12860003 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR IT BAND CROSSOVER SYNDROME - IT BAND TENDINITIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021; (LEFT KNEE).

  Patient problems: Loss of Range of Motion; Muscle/Tendon Damage; Muscular Rigidity; Pain; Synovitis

  MAUDE report 12341489 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO THE KNEE WAS UNSTABLE AND PUT IN A THICKER INSERT. DOI: (B)(6) 2018 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11732749 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANTERIOR SCAR DEVELOPMENT, PATELLAR GRINDING, PAIN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2021, DATE OF INTERVENTION: (B)(6) 2021, (LEFT KNEE). TREATMENT: ARTHROSCOPIC DEBRIDEMENT OF ADHESIONS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11334533 ↗