NA 1294-56-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295026716), received between Dec 10, 2019 and Feb 4, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2023Adverse 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) 2020. DATE OF REVISION: (B)(6) 2022. (RIGHT KNEE) TREATMENT: REVISION; FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16301901 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED LAST (B)(6) 2021 DUE TO STAGE 1 INFECTION. SURGERY WAS DONE AT (B)(6) HOSPITAL. THE 1ST REVISION WAS DONE ON (B)(6) 2016. DOI: (B)(6) 2016, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12542219 ↗
• InjuryDec 10, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE TIBIAL AUGMENT WAS NOT COMPLETELY SCREW DOWN AND IT CREATED SOME METALOSIS. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9446215 ↗
• InjuryDec 10, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE TIBIAL AUGMENT WAS NOT COMPLETELY SCREW DOWN AND IT CREATED SOME METALLOSIS. DOI: UNKNOWN. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Foreign Body Reaction; No Code Available

  MAUDE report 9446206 ↗