AML 1557-03-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295059240), received between Aug 1, 2017 and Feb 28, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2023Fracture; Fracture

  HCP IS REPORTING TO NCA/BFARM: "PRESENTATION ON (B)(6) 2022 IN EMERGENCY DEPARTMENT. REFERRAL FROM OUTPATIENT ORTHOPEDIST WITH FRACTURED HIP-TEP STEM RIGHT SIDE. THERE WAS PAIN IN THE HIP FOR OVER A YEAR. ACUTE INCREASE OF PAIN SINCE 4 WEEKS. X-RAY IN OUR AMBULANCE WITH FRACTURE OF THE STEM. HIP-TEP IMPLANTED ON THE RIGHT IN 2002 WITH TWO-STAGE REPLACEMENT IN 2003. STEM REVISION SURGERY ON (B)(6) 2023." DOI: (B)(6) 2003. DOR: (B)(6) 2023. RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16452627 ↗
• InjuryJul 12, 2019Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  IT WAS REPORTED THAT THIS 5/8 COATED AML STEM FRACTURED PROXIMALLY WHERE THE METAPHYSEAL PORTION TAPERED DOWN TO THE STRAIGHT CYLINDER DIAPHYSEAL PART. THE STEM WAS REMOVED. THE CUP WAS RETAINED AND A NEW LINER INSERTED. IT WAS NOTED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8785130 ↗
• InjuryJan 2, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ABDUCTOR MUSCLE REPAIR. DOI: (B)(6) 2004 - DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: Pain; Test Result; Tissue Damage

  MAUDE report 8207786 ↗
• InjurySep 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM EXTREME PAIN. DOI: (B)(6) 2010; DOR: NONE REPORTED; (RIGHT HIP).

  Patient problems: Burning Sensation; Limited Mobility Of The Implanted Joint; Pain; Swelling

  MAUDE report 7886594 ↗
• InjurySep 10, 2018Fracture; Fracture

  THE PATIENT HAD A PRIMER HIP SURGERY ON (B)(6) 2001. THE DOCTOR USED AML STEM. NOW (AFTER 17 YEARS) THIS STEM HAS BROKEN - ONLY THE STEM, THE FEMUR IS UNDAMAGED.

  Patient problems: Not Applicable

  MAUDE report 7859748 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ALLEGES DEVICE FAILED CAUSING INJURIES, INFECTION POST-REVISION AND BONE DAMAGE. AFTER THE REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION. REVISION NOTES REPORTED A LOT OF PUS, GREATER TROCHANTER WAS VERY SOFT AND CRACKED, AND CRACKED FEMORAL SHAFT. CLINICAL NOTES REPORTED PSOAS ABSCESS, PAIN, DISTRESS AND AMBULATION DIFFICULTIES. LABORATORY RESULT SHOWS METAL ION LEVELS ABOVE 7PPB. DOI: (B)(6) 2004; DOR: (B)(6) 2011; LEFT HIP.

  Patient problems: Abscess; Distress; Inflammation; Injury; Pain; Unspecified Infection

  MAUDE report 7163422 ↗
• InjuryAug 3, 2017Loss of or Failure to Bond; Loss of Osseointegration; Loss of or Failure to Bond; Loss of Osseointegration

  PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: Discomfort; Foreign Body Reaction; Inadequate Osseointegration; No Code Available; Osteolysis; Pain

  MAUDE report 6764017 ↗
• InjuryAug 1, 2017Loss of or Failure to Bond; Corroded; Degraded; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available; Loss of or Failure to Bond; Corroded; Degraded; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available

  PPF ALLEGES METAL WEAR AND LOOSENING OF STEM.

  Patient problems: Abscess; Cellulitis; Foreign Body Reaction; Hematoma; Host-Tissue Reaction; Inadequate Osseointegration; Osteolysis; Pain; Tissue Damage

  MAUDE report 6757585 ↗