SOLUTION SYSTEM 1571-15-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM W/ POROCOAT 8 Inches 15.0mm STD · Class 2 · Implant
All models of SOLUTION SYSTEM (64)
Data updated Oct 16, 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 10603295060765), received between Dec 18, 2018 and May 9, 2019 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Biocompatibility1
- Unintended Movement1
Patient problems
- Pain2
- Limb Fracture1
- No Code Available1
- Swelling1
- Test Result1
- Tissue Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2019Unintended Movement; Unintended Movement
CLINICAL ADVERSE EVENT RECEIVED FOR LEFT PERIPROSTHETIC FEMUR FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2005, DOE: (B)(6) 2019, (LEFT HIP).
Patient problems: Limb Fracture; Pain; Swelling
MAUDE report 8598059 ↗InjuryDec 18, 2018Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem
LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM A ACETABULAR CUP THAT EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED. PAIN AND INHIBITION TO WALK ARE ALSO ALLEGED. UPDATE AD 29 JUN 2018 RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.
Patient problems: No Code Available; Pain; Test Result; Tissue Damage
MAUDE report 8173710 ↗
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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