AML 1557-07-000Recalls & reported problems
Depuy International Ltd · AML HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM 5/8 POROCOAT 18.0mm MMA · Class 2 · Implant
All models of AML (8)
Data updated Oct 18, 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 10603295059288), received between Jul 19, 2019 and Jul 19, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of Osseointegration” (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
- Loss of Osseointegration1
Patient problems
- Calcium Deposits/Calcification1
- Foreign Body Reaction1
- Inadequate Osseointegration1
- Injury1
- Joint Disorder1
- Loss of Range of Motion1
- No Code Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2019Loss of Osseointegration; Loss of Osseointegration
PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PAIN, EXTENSIVE HETEROTOPIC BONE FORMATION, MOTION OF THE FEMORAL COMPONENT AND FOREIGN BODY REACTION. REVISION NOTES REPORTED, EXTENSIVE SCAR TISSUE AND HETEROTOPIC BONE FORMATION INFILTRATING INTO THE GLUTEUS MEDIUS AND MINIMUS. THE FEMORAL COMPONENT DID NOT APPEAR TO BE ANY BONE INGROWTH ON THE IMPLANT, BUT THERE IS EXTENSIVE SCAR GROWTH. THERE WAS GRANULATION TISSUE WITHIN THE ACETABULAR CAVITY, LIMITED RANGE OF MOTION AND LEG LENGTH DISCREPANCY. SURGICAL PATHOLOGY REPORT BENIGN, IRREGULAR FRAGMENT OF TRABECULAR BONE WITH FIBROSIS OF THE ACETABULAR TISSUE, FOREIGN BODY AND BONE FRAGMENT. DOI: (B)(6) 2002; DOR: (B)(6) 2010, LEFT HIP.
Patient problems: Calcium Deposits/Calcification; Foreign Body Reaction; Inadequate Osseointegration; Injury; Joint Disorder; Loss of Range of Motion; No Code Available; Pain; Scar Tissue
MAUDE report 8809035 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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