NA 1294-35-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295025924), received between Oct 6, 2023 and Nov 9, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. DATE OF IMPLANT: (B)(6) 2012. DATE OF REVISION: (B)(6) 2023. (RIGHT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED. (B)(4) OPERATIVE NOTE AD (B)(6) 2023 AND (B)(4) CLINICAL NOTE AD (B)(6) 2023 WERE REVIEWED BY A CLINICIAN. ON (B)(6) 2023, THE PATIENT UNDERGOES A R KNEE REVISION SECONDARY TO PAIN, SWELLING AND INSTABILITY AFTER A FALL. XRAYS INDICATE LOOSENING WITH VALGUS COLLAPSE OF THE FEMORAL COMPONENT. INTRA-OPERATIVELY, THE FEMORAL SUBSIDENCE AND LOOSENING WERE CONFIRMED, THOUGH LOOSENING INTERFACE WAS NOT PROVIDED. MILD WEAR WAS NOTED ON THE PATELLAR COMPONENT, THOUGH IT WAS NOT REVISED.

  Patient problems: Discomfort; Fall; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 18100440 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN. EVENT IS CONSIDERED MILD. UNKNOWN IF EVENT IS CONSIDERED SERIOUS. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2012, DATE OF EVENT: (B)(6) 2023, (RIGHT KNEE). TREATMENT: CT SCAN FOR EVALUATION OF INTERFACES.

  Patient problems: Pain

  MAUDE report 17885124 ↗