AML 1554-01-180Recalls & reported problems
Depuy Orthopaedics, Inc. · AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 18.0mm SMALL STATURE 150mm LENGTH 43mm 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 10603295058274), received between Sep 12, 2018 and Oct 14, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 Problem1
- Insufficient Device Problem Information1
- Osseointegration Problem1
Patient problems
- Limb Fracture2
- Discomfort1
- Fall1
- Inadequate Osseointegration1
- Inflammation1
- Limited Mobility Of The Implanted Joint1
- Pain1
- Test Result1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE PERI PROSTHETIC PLATING OF FEMUR DUE TO FRACTURE BELOW HIP STEM. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.
Patient problems: Limb Fracture
MAUDE report 15605590 ↗InjuryJan 11, 2022Osseointegration Problem; Osseointegration Problem
PATIENT FELL AND SUFFERED A PERIPROSTHETIC FRACTURE. IT WAS DISCOVERED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.
Patient problems: Fall; Inadequate Osseointegration; Limb Fracture
MAUDE report 13222691 ↗InjurySep 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
LITIGATION ALLEGES PAIN, ELEVATED IONS, DISCOMFORT, INFLAMMATION, LIMITED MOBILITY, AND METAL WEAR. DOI: (B)(6) 2008; DOR: NONE REPORTED (RIGHT HIP).
Patient problems: Discomfort; Inflammation; Limited Mobility Of The Implanted Joint; Pain; Test Result
MAUDE report 7869933 ↗
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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