SIGMA 94-0012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295223382), received between Jan 26, 2021 and Aug 30, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS. 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: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 17652056 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION AND SEVERE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO EITHER DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND PATELLA WERE REMOVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17216881 ↗
• InjuryJul 18, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO CLUNK. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2022. LEFT KNEE. TREATMENT: REMOVAL OF INSERT. WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: Adhesion(s); Insufficient Information; Joint Laxity; Pain; Unspecified Musculoskeletal problem

  MAUDE report 15046211 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OFFICE NOTES (B)(6)2021 INDICATE THE PATIENT¿S RIGHT KNEE IS DOING WELL. THE LEFT KNEE IS NOTED TO HAVE FELT A LARGE POP WHILE GETTING BACK INTO BED. SHE FELT LIKE HER KNEE SHIFTED. SHE HAD TO MOVE HER KNEE AND THEN IT FELT BETTER, BUT IT WAS QUITE SWOLLEN. THE LEFT KNEE THAT IS VERY SORE AND VERY UNSTABLE. PHYSICAL EXAM OF THE LEFT KNEE REVEALS GROSS INSTABILITY WITH PCL DYSFUNCTION AND DECREASED RANGE OF MOTION. RADIOGRAPHIC IMPRESSION: STABLE KNEE ARTHROPLASTY ON THE RIGHT. QUESTION POLY SPINOUT AND THE POLY 180 DEGREES FROM OPTIMAL POSITION LEFT KNEE. REVISION OPERATIVE NOTES (B)(6)2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO GLOBAL INSTABILITY, SWELLING, MCL INSUFFICIENCY, PCL RUPTURE, SPINOUT OF THE TIBIAL BEARING 180 DEGREES AND TIBIAL-FEMORAL SUBLUXATION. INSERT AND FEMORAL COMPONENT REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 11231158 ↗