SOLUTION SYSTEM 1571-13-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM W/ POROCOAT 8 Inches 12.5mm 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 10603295060741), received between Mar 14, 2019 and Nov 24, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Ambulation or Postural Difficulties1
- Bone Fracture(s)1
- No Code Available1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2020Fracture; Fracture
AN OFFICIAL LETTER HAS BEEN RECEIVED FROM THE HEALTH AUTHORITY WITH BELOW COMPLAINT DEFINITION: A PATIENT (NAME IS DARKENED IN ATTACHED FILE) HAD GONE THROUGH A HIP REPLACEMENT SURGERY IN (B)(6) 2018 AND HAD NO ISSUES UNTIL A NORMAL WALKING GONE IN (B)(6) 2020 WHERE THE PATIENT COULDN'T TAKE A STEP. IN THE RADIOLOGY IMAGING PERFORMED THE NEXT DAY ON (B)(6) 2020, IT WAS SEEN THE IMPLANT WAS BROKEN AND IT PENETRATED FEMUR BY BREAKING THE BONE AS WELL. THE PATIENT HAD ANOTHER SURGERY ON (B)(6) 2020. THE PATIENT ALSO CLAIMS THAT IN 2015 AND 2018, THERE WERE MANUFACTURING DEFECTS ON THE DEVICES AND THE PATIENTS HAD THESE IMPLANTS WERE RE-OPERATED DUE TO IMPLANT BREAKAGE.
Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s)
MAUDE report 10896441 ↗InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO BROKEN FEMORAL STEM.
Patient problems: No Code Available; Pain
MAUDE report 8420305 ↗
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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