NA 1011-02-501Recalls & reported problems
Depuy Orthopaedics, Inc. · ROOF PILE SCREW 6.5mm x 25mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295000334), received between Mar 20, 2019 and Mar 20, 2019 — classified as 3 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (3 reports).
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 18, 2026.
Most reported problems
Device problems
- Osseointegration Problem3
Patient problems
- Discomfort3
- Inadequate Osseointegration3
- Limited Mobility Of The Implanted Joint3
- Pain3
- Tissue Damage3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2019Osseointegration Problem; Osseointegration Problem
PPF ALLEGES CONSTRAINED LINER, METALLOSIS AND LOOSENING OF CUP. DOI: (B)(6) 2008 - DOR: (B)(6) 2013 (RIGHT HIP).
Patient problems: Discomfort; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Pain; Tissue Damage
MAUDE report 8435644 ↗InjuryMar 20, 2019Osseointegration Problem; Osseointegration Problem
PPF ALLEGES CONSTRAINED LINER, METALLOSIS AND LOOSENING OF CUP. DOI: (B)(6) 2008 - DOR: (B)(6) 2013 (RIGHT HIP).
Patient problems: Discomfort; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Pain; Tissue Damage
MAUDE report 8435624 ↗InjuryMar 20, 2019Osseointegration Problem; Osseointegration Problem
PPF ALLEGES CONSTRAINED LINER, METALLOSIS AND LOOSENING OF CUP. DOI: (B)(6) 2008 - DOR: (B)(6) 2013 (RIGHT HIP).
Patient problems: Discomfort; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Pain; Tissue Damage
MAUDE report 8435606 ↗
Other Mesh, surgical, acetabular, hip, prosthesis devices
- NA 1011-40-025Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis13 reports
- NA 1011-40-030Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis13 reports
- NA 1011-40-040Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis11 reports
- NA 1011-40-020Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis11 reports
- NA 1011-40-035Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis9 reports
- NA 1011-40-015Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis8 reports
- NA 1011-71-000Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis4 reports
- Contour 71337156Smith & Nephew, Inc. · Mesh, surgical, acetabular, hip, prosthesis3 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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