SOLUTION SYSTEM 1572-08-150Recalls & reported problems
Depuy Orthopaedics, Inc. · SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE RIGHT 8 Inches 15.0mm 45mm OFFSET · 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 10603295061588), received between Feb 11, 2019 and Oct 17, 2019 — classified as 2 injuries.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loss of Osseointegration1
Patient problems
- Bone Fracture(s)2
- No Code Available2
- Adhesion(s)1
- Inadequate Osseointegration1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PPF AND MEDICAL RECORDS RECEIVED. PPF HAS NEW ALLEGATIONS REPORTED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO DISLOCATED RIGHT HIP. OPERATIVE NOTES REPORTED, THE GLUTEUS MAXIMUS FIBERS WERE VERY ADHERENT TO THE UNDERLYING ABDUCTORS AND THERE WAS A CHRONIC NONUNION OF THE GREATER TROCHANTER. THE LEG WAS SHORT BY ABOUT 2.5 INCHES DUE TO CHRONIC DISLOCATION. DOI: (B)(6) 2007; DOR: (B)(6) 2007 (RIGHT HIP); PLEASE SEE (B)(4) FOR THE FIRST REVISION.
Patient problems: Adhesion(s); Bone Fracture(s); No Code Available
MAUDE report 9204888 ↗InjuryFeb 11, 2019Loss of Osseointegration; Loss of Osseointegration
PPF AND IMPLANT RECORD RECEIVED. PPF ALLEGES FRACTURE (BONE), INFECTION AND LOOSENING OF STEM. DOI: (B)(6) 2009 - DOR: NONE REPORTED (RIGHT HIP) (CUP, SCREW). DOI: (B)(6) 2009 - DOR: (B)(6) 2011 (RIGHT HIP) (HEAD, STEM, LINER).
Patient problems: Bone Fracture(s); Inadequate Osseointegration; No Code Available; Unspecified Infection
MAUDE report 8325001 ↗
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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