ATTUNE 1547-09-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295382898), received between Dec 1, 2020 and Dec 1, 2020 — 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.

• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANEMIA- POST OP IRON SUBSTITUTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: INJECTED MEDICATION (UNSPECIFIED).

  Patient problems: Anemia

  MAUDE report 10924752 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANEMIA- POST OP IRON SUBSTITUTION EVENT IS NOT SERIOUS AND IS CONSIDERED MILD EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020; DATE OF EVENT (ONSET): (B)(6) 2020; (RIGHT KNEE). TREATMENT: INJECTED MEDICATION (UNSPECIFIED).

  Patient problems: Anemia

  MAUDE report 10924712 ↗