SOLUTION SYSTEM 1572-02-150Recalls & reported problems
Depuy Orthopaedics, Inc. · SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT LARGE STATURE 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 10603295061441), received between Oct 15, 2018 and Jan 2, 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
- Failure to Osseointegrate1
Patient problems
- No Code Available2
- Inadequate Osseointegration1
- Injury1
- Pain1
- Test Result1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem
LITIGATION ALLEGES THAT THE PATIENT SUFFERED AND CONTINUES TO SUFFER FROM PAIN, SERIOUS BODILY INJURY, AND HIGH METAL LEVELS. UPDATE 25 JUNE 2018 RECEIPT OF PPF AND IMPLANT RECORDS. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF ALLEGED BONE FRACTURE AND ELEVATED METAL IONS.
Patient problems: Injury; No Code Available; Pain; Test Result
MAUDE report 8208057 ↗InjuryOct 15, 2018Failure to Osseointegrate; Failure to Osseointegrate
REMOVED HEAD, CUP, LINER AND POLY. STEM WAS LOOSE. RIGHT HIP REVISION.
Patient problems: Inadequate Osseointegration; No Code Available
MAUDE report 7966931 ↗
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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