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AML 1554-02-105Recalls & reported problems

Depuy Orthopaedics, Inc. · AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 10.5mm LARGE STATURE 160mm LENGTH 40mm OFFSET · Class 2 · Implant

All models of AML (23)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295058328), received between Nov 27, 2018 and Aug 26, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Biocompatibility1
  • Insufficient Device Problem Information1

Patient problems

  • Test Result3
  • Discomfort2
  • Pain2
  • No Code Available1
  • Swelling1
  • Tissue Damage1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE REC¿D (3/20/2014) - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM DISCOMFORT AND SWELLING. UPDATE AD 24 JUL 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND MEDICAL RECORDS. PPF ALLEGES ABDUCTOR MUSCLE REPAIR. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO FAILED TOTAL HIP ARTHROPLASTY AND ELEVATED METALS IONS LEVEL. REVISION NOTES STATED, THE CUP WAS VERTICAL BUT THERE WAS NO OBVIOUS SUBLUXATION, IMPINGEMENT OR DISLOCATION. UPDATED THE IMPLANT DATE, PATIENT IDENTIFIER AND THE DETAILS OF THE IMPACTED PRODUCTS. AN IMPACTED PRODUCT RECORD FOR THE STEM WAS ADDED DUE TO ELEVATED METAL IONS. DOI: (B)(6) 2006 - DOR: (B)(6) 2013 (RIGHT HIP, FIRST REVISION). PLEASE SEE (B)(4) FOR THE SECOND REVISION.

    Patient problems: Discomfort; No Code Available; Pain; Swelling; Test Result; Tissue Damage

    MAUDE report 8932002 ↗
  • InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

    LITIGATION ALLEGES PAIN AND DISCOMFORT. UPDATE: IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: NONE REPORTED, (LEFT HIP).

    Patient problems: Discomfort; Pain; Test Result

    MAUDE report 8432655 ↗
  • InjuryNov 27, 2018Biocompatibility; Biocompatibility

    PPF ALLEGES LOOSENING OF CUP AND ELEVATED METAL IONS. ADDED STEM, CUP, AND BONE SCREWS IN THE IMPACTED PRODUCTS BECAUSE OF THE ALLEGED LOOSENING AND ELEVATED METAL IONS. DOI: (B)(6) 2006 - DOR: (B)(6) 2016 (LEFT HIP).

    Patient problems: Test Result

    MAUDE report 8105627 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources and updates

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