AML 1554-02-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295058359), received between Aug 30, 2017 and Dec 12, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (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 16, 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.

• InjuryDec 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH MID THIGH PAIN. X-RAYS SHOWED A FRACTURE IN THE STEM ROUGHY WHERE THE FLANGE BEGINS. PATIENT SAYS NO TRAUMA OCCURRED, WAS WALKING AROUND ON VACATION. AFTER RE-EXAMINING X-RAYS FROM 2018, IT APPEARS THERE MAY HAVE BEEN THE BEGINNING OF A FRACTURE. AT THE TIME, PATIENT PRESENTED WITH BURSITIS SYMPTOMS. CURRENT X-RAYS SHOW REMODELING LATERAL TO THE STEM FRACTURE. NO SIGN OF INFECTION. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2008. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Inflammation; Pain

  MAUDE report 15958781 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ELEVATED METAL IONS AFTER 1ST REVISION. DOI: (B)(6) 2008 - DOR: (B)(6) 2011; (LEFT HIP).

  Patient problems: No Code Available; Test Result

  MAUDE report 8416386 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES INJURY, DISCOMFORT, PAIN, BURSITIS, WALKING DIFFICULTY, DECREASED/LIMITED MOBILITY, AND CLICKING AND POPPING SOUND. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO FAILED LEFT TOTAL HIP REPLACEMENT WITH METAL ON METAL ARTICULATION, PERSISTENT PAIN, AND CORTICAL STRESS REACTION AT DISTAL TIP OF THE STEM WITHOUT VISIBLE EVIDENCE OF METAL ON METAL CORROSION. REVISION NOTES INDICATED THAT THERE WAS EXTENSIVE SCAR THROUGHOUT THE HIP JOINT ITSELF.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inflammation; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Scar Tissue; Test Result

  MAUDE report 8256806 ↗
• InjuryJul 10, 2018Break; Break

  THE PATIENT WAS REVISED TO ADDRESS BROKEN AML STEM AND LOOSENING AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO INDICATED THAT THE STEM FRACTURED AND A NEW STEM AND HEAD WERE IMPLANTED. A NEW POLY WAS INSERTED AS WELL. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Discomfort; Inadequate Osseointegration; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Pain; Weakness

  MAUDE report 7673185 ↗
• InjuryAug 30, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; No Information

  MAUDE report 6833119 ↗