AML 1554-04-000Recalls & reported problems

Depuy International Ltd · AML HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM 5/8 POROCOAT 13.5mm STD · Class 2 · Implant

All models of AML (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295058519), received between Jul 14, 2017 and Nov 6, 2018 — classified as 2 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 18, 2026.

Most reported problems

Device problems

Biocompatibility1
Migration or Expulsion of Device1

Patient problems

Discomfort1
Inflammation1
No Code Available1
No Information1
Pain1
Test Result1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryNov 6, 2018Biocompatibility; Biocompatibility
LITIGATION ALLEGED THAT AFTER THE SURGERY, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS RIGHT AND LEFT THIGH AND GROIN. HE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. UPDATE AD 1 MAY 2018 RECEIPT OF PPF AND STICKER SHEETS. PPF HAS NO ALLEGATIONS AND NO REVISION REPORTED. THE UNKNOWN DEPUY PINNACLE HIP THAT WAS REPORTED IN THE WPC WAS CHANGED TO PINNACLE METAL LINER. ADDED HEAD AND STEM DUE TO A LARGE AMOUNT OF TOXIC COBALT CHROMIUM. UPDATED DOB AND ADDED LAW FIRM IN THE FACILITY NAME.
Patient problems: Discomfort; Inflammation; No Code Available; Pain; Test Result
MAUDE report 8041249 ↗
InjuryJul 14, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
THE PATIENT WAS REVISED TO ADDRESS STEM SUBSIDENCE. IT WAS ALSO REPORTED THAT THE REMOVED PARTS WERE REPLACED WITH A NEW LINER (PINNACLE)/STEM/HEAD BUT THE STEM AND HEAD WAS NOT OURS-A COMPETITIVE SYSTEM WAS USED.
Patient problems: No Information
MAUDE report 6713504 ↗

Device details

UDI-DI	`10603295058519`
Brand	AML
Model	1554-04-000
Catalog no.	155404000
Company	Depuy International Ltd
Product code	LPH · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Class	Class 2
FDA submission	K953694
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Coated hip femur prosthesis, modular

A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

PINNACLE 1217-25-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
735 reports
NA 1365-52-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
683 reports
APEX 1246-03-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
3 deaths613 reports
PINNACLE 1217-20-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
2 deaths590 reports
PINNACLE 1217-30-500
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
1 death484 reports
NA 1365-53-000
Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
404 reports
PINNACLE ALTRX 1221-36-054
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
388 reports
PINNACLE ALTRX 1221-32-050
Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
386 reports

All PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices →

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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