AML 1554-02-210Recalls & reported problems
Depuy Orthopaedics, Inc. · AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 21.0mm LARGE STATURE 155mm LENGTH 45mm 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 10603295058410), received between Jan 28, 2025 and Jan 28, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond1
Patient problems
- Inadequate Osseointegration1
- Malunion of Bone1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT ON (B)(6) 2020 PATIENT WAS RE-IMPLANTED WITH DEPUY POLY LINER, CERAMIC HEAD AND AML STEM. DURING EXTRACTION AND RE-IMPLANTATION OF THE DEPUY AML STEM, AN INTRAOPERATIVE PERFORATION FRACTURE OF THE DISTAL FEMUR OCCURRED. THE PATIENT REQUIRED A FEMORAL STRUT ALLOGRAFT WITH 5 CERCLAGE CABLES AND A GREATER TROCHANTER PLATE TO TREAT (ALL COMPETITOR PRODUCTS). A CT SCAN ON (B)(6) 2021 REPORTS A PERIPROSTHETIC FRACTURE NON-UNION OF THE PATIENT'S LEFT FEMUR, INVOLVING CERCLAGE CABLES AND A GREATER TROCHANTER HOOK (MANUFACTURER NOT PROVIDED). THERE IS ALSO NO INFORMATION ON WHEN THE FRACTURE OCCURRED OR WHEN IT WAS INITIALLY REPAIRED. ALL LEFT TOTAL HIP PRODUCTS WERE STILL PRESENT. ON (B)(6) 2021, PATIENT'S LEFT HIP WAS REVISED TO ADDRESS A LOOSE FEMORAL STEM IMPLANT SECONDARY TO A PREVIOUS PERIPROSTHETIC AND GREATER TROCHANTER FEMUR FRACTURES, THAT HAD NOT PROPERLY HEALED AND ULTIMATELY FAILED WITH NON-UNION AND LOOSENING OF THE FEMUR IMPLANT. STEM AND HEAD WERE REVISED TO A RECLAIM STEM AND HEAD, WHILE RETAINING THE EXISTING CUP, SCREWS, AND LINER. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT HIP.
Patient problems: Inadequate Osseointegration; Malunion of Bone
MAUDE report 21253167 ↗
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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