SIGMA 96-2367Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295242567), received between Jun 22, 2017 and Sep 27, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON WASHED OUT AND EXCHANGED THE INSERT. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20321227 ↗
• InjuryMay 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATED HIP INSERT DURING A FALL. THERE WAS NO SURGICAL DELAY AND NO BROKEN IMPLANTS OR INSTRUMENTS. FEMORAL REVISION WAS PERFORMED AND EXPLANTED FEMUR AND STEM REFERENCE AND LOT NUMBERS WERE NOT READABLE AND THUS UNKNOWN. THERE WAS NO LOOSENING. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 19220232 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2016. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16618525 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. WASHOUT/ I&D WAS PERFORMED. POLY WAS REPLACED. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16598385 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE SWELLING/HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2016. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: ASPIRATED FOR BLOOD AND MILD CLOUDINESS; SENT FOR SYNOVASURE AND CAME BACK NEGATIVE FOR BOTH AEROBIC AND ANAEROBIC ORGANISM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 16149540 ↗
• InjurySep 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15397612 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO TIBIA COLLAPSED ON THE MEDIAL SIDE AND CAUSED PATIENT DISCOMFORT AND INSTABILITY. THE DOCTOR REMOVED ALL COMPONENTS AND REPLACED WITH A NEW REVISION KNEE TO CORRECT PATIENTS INSTABILITY. DOI : (B)(6) 2008; DOR : (B)(6) 2022 LEFT SIDE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 13335079 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INFECTION DATE OF IMPLANTATION: (B)(6) 2018; DATE OF REVISION #1: (B)(6) 2020; DATE OF REVISION #2: (B)(6) 2021; (RIGHT KNEE). TREATMENT: ALL PRODUCTS EXPLANTED AND ANTIBIOTIC SPACER PLACED.

  Patient problems: Adhesion(s); Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 12933187 ↗
• InjuryNov 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SOFT TISSUE LAXITY. POLY SWAP WAS DONE, SZ5 TC3 25MM RP POLY WAS UPSIZED TO A 30MM RP TC3 POLY. PRIMARY SURGERY DATE AND LOCATION ARE UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12850129 ↗
• InjuryDec 11, 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 INFECTION DATE OF IMPLANTATION: (B)(6) 2018, DATE OF REVISION: (B)(6) 2020, (RIGHT KNEE). TREATMENT: TIBIAL INSERT REVISED.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Low Blood Pressure/ Hypotension; Pain; Sepsis; Swelling/ Edema

  MAUDE report 10993544 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUET TO CHRONIC INFECTION. POLY SWAP WITH AN IRRIGATION AND DEBRIDEMENT WAS DONE. NO OTHER INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10689442 ↗
• InjuryJun 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AFTER A REVISION. SURGEON DID AN I&D AND POLY SWAP.

  Patient problems: Unspecified Infection

  MAUDE report 6661140 ↗