AML 1557-02-000Recalls & reported problems
Depuy International Ltd · AML HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM 5/8 POROCOAT 10.5mm MMA · Class 2 · Implant
All models of AML (8)
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 10603295059233), received between Feb 8, 2019 and Oct 13, 2023 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (4 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.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Ambulation or Postural Difficulties2
- Pain2
- Discomfort1
- Insufficient Information1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 13, 2023Fracture; Fracture
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO SURGICAL DELAY REPORTED.
Patient problems: Discomfort
MAUDE report 17930439 ↗InjuryDec 5, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
HCP IS REPORTING TO NCA/BFARM: "MS.(B)(6) WAS ADMITTED TO THE HOSPITAL VIA OUR CENTRAL EMERGENCY ROOM WITH EXISTING SEVERE PAIN SINCE THE MORNING OF (B)(6) 2022 IN THE RIGHT HIP JOINT WITH IMPLANTED HIP-TEP, AFTER SHE HAD HEARD A BANG IN THE MORNING HOURS WHILE BENDING OVER. SHE HAD BEEN MOBILE ON FOREARM CRUTCHES SINCE THEN. HIP PAIN HAD BEEN PRESENT FOR MORE THAN 2 YEARS. SINCE THE CURRENT YEAR, THEY WERE INCREASING."
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 15914832 ↗InjuryMay 6, 2022Fracture; Fracture
AML FEMORAL STEM WAS BROKEN AND NEEDED TO BE REVISED AND REPLACED WITH A DIFFERENT STEM.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 14307594 ↗InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PPF ALLEGES INFECTION. DOI: (B)(6) 2004 - DOR: (B)(6) 2009 (RIGHT HIP).
Patient problems: Pain; Unspecified Infection
MAUDE report 8342865 ↗InjuryFeb 8, 2019Fracture; Fracture
A HIP REVISION WAS PERFORMED ON A PATIENT FOR A REMOVAL OF A FRACTURED AML PROSTHESIS.
Patient problems: No Code Available
MAUDE report 8320528 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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