AML 1554-03-180Recalls & reported problems
Depuy Orthopaedics, Inc. · AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 18.0mm LARGE STATURE HIGH OFFSET 160mm LENGTH 52mm OFFSET · Class 2 · Implant
All models of AML (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295058472), received between Nov 16, 2017 and Jul 8, 2020 — classified as 5 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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 16, 2026.
Most reported problems
Device problems
- Loss of Osseointegration3
- Adverse Event Without Identified Device or Use Problem1
- Biocompatibility1
Patient problems
- Pain3
- Inadequate Osseointegration2
- No Code Available2
- Tissue Damage2
- Discomfort1
- Hypersensitivity/Allergic reaction1
- Limited Mobility Of The Implanted Joint1
- Not Applicable1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2020Loss of Osseointegration; Loss of Osseointegration
THE PATIENT WAS REVISED TO ADDRESS PAIN/LOOSE STEM. DOI: (B)(6) 2007, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.
Patient problems: Inadequate Osseointegration; No Code Available; Pain
MAUDE report 10245896 ↗InjuryApr 10, 2019Biocompatibility; Biocompatibility
PPF ALLEGES PSEUDOTUMOR, ELEVATED METAL IONS AND METALLOSIS. DOI: (B)(6) 2003 - DOR: (B)(6) 2013; (LEFT HIP).
Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Pain; Test Result; Tissue Damage
MAUDE report 8499032 ↗InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LITIGATION ALLEGES INFECTION. DOI: (B)(6) 2005 - DOR: (B)(6) 2014 (LEFT HIP).
Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Tissue Damage; Unspecified Infection
MAUDE report 8292809 ↗InjuryApr 10, 2018Loss of Osseointegration; Loss of Osseointegration
PATIENT WAS REVISED TO ADDRESS STEM SUBSIDENCE AND LOOSENING AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2006; DOR: (B)(6) 2018: LEFT HIP.
Patient problems: Inadequate Osseointegration; Not Applicable
MAUDE report 7412805 ↗InjuryNov 16, 2017Loss of Osseointegration; Loss of Osseointegration
DER STATES THAT THE PATIENT HAD HIP PAIN AND FELT THAT THE STEM WAS LOOSE AND HAD FIBROUS GROWTH. LOOSENING INTERFACE AT BONE TO IMPLANT INTERFACE.
Patient problems: Pain
MAUDE report 7037310 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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