AML 1554-03-225Recalls & reported problems
Depuy Orthopaedics, Inc. · AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 22.5mm LARGE STATURE HIGH OFFSET 155mm 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295058502), received between Feb 1, 2024 and Feb 1, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Adhesion(s)1
- Ambulation or Postural Difficulties1
- Deformity/ Disfigurement1
- Discomfort1
- Distress1
- Hypersensitivity/Allergic reaction1
- Loss of Range of Motion1
- Metal Related Pathology1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AFTER REVIEW PATIENT WAS REVISED DUE TO FAILED METAL-ON-METAL TOTAL LEFT ARTHROPLASTY WITH RECURRENT DISLOCATION AND ELEVATED SERUM COBALT AND CHROMIUM. THE PATIENT ALSO HAD PSEUDOTUMOR WITH DEFICIENT ABDUCTORS WHICH WAS EXCISED. THE FEMORAL HEAD WAS REMOVED. THE FEMUR WAS DISSECTED IN PREPARATION FOR EXTENDED TROCHANTERIC OSTEOTOMY. BUR AND FLEXIBLE OSTEOTOMIES WERE USED TO BREAK UP THE BONE-IMPLANT INTERFACE. THE FEMORAL STEM WAS EVENTUALLY REMOVED. PRIOR SCAR TISSUE WAS EXCISED. AN ACETABULAR EXPLANT SYSTEM WAS USED TO REMOVE THE CUP WITH MINIMAL BONE LOSS.
Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Deformity/ Disfigurement; Discomfort; Distress; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Pain; Unspecified Tissue Injury
MAUDE report 18623376 ↗
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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