AML 1554-03-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295058434), received between Sep 21, 2017 and Jun 19, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR ORIGINAL COMPLAINT.- PATIENT REVISED DUE TO PAIN. PPF ALLEGES INFECTION, METALLOSIS, METAL WEAR, PSEUDOTUMOR AND ELEVATED METAL IONS. DOI: (B)(6) 2003, DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8711589 ↗
• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AND ELEVATED METAL IONS. DOI (B)(6) 2003, DOR (B)(6) 2011 (LEFT HIP).

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8335467 ↗
• InjuryJan 21, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN, OSTEOLYSIS AND LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available; Osteolysis; Pain

  MAUDE report 8265262 ↗
• InjuryJan 25, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018: PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES CONSTANT PAIN AND WALKING DIFFICULTY. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS NON-SEPTIC LOOSENING OF THE FEMORAL PROSTHESIS. REVISION NOTE STATED, THE STEM FOUND TO HAVE VERY LITTLE BONY INGROWTH. THE LINER APPEARED TO HAVE NO SIGNIFICANT WEAR, IT WAS NOT REMOVED AND THE CUFF SHOWED NO EVIDENCE OF ANY LOOSENING. CLINICAL VISITS REPORTS OF CLICKING, TROCHANTERIC BURSITIS, SYNOVITIS. DOI: (B)(6) 2005, DOR: (B)(6) 2011 (LEFT HIP RE-REVISION).

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 7218643 ↗
• InjurySep 21, 2017Fracture; Fracture

  PATIENT WAS REVISED TO ADDRESS BROKEN AML STEM. THE TRUNNION WAS BROKEN.

  Patient problems: Unspecified Infection

  MAUDE report 6883157 ↗