NA 1011-40-035Recalls & reported problems
Depuy Orthopaedics, Inc. · SELF TAPPING ROOF PILE SCREW 35mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295000457), received between Nov 7, 2018 and Mar 8, 2021 — classified as 9 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Loss of Osseointegration2
- Fracture1
Patient problems
- No Code Available8
- Unspecified Infection6
- Inadequate Osseointegration2
- Pain2
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2021Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT BROKE THE PROTRUSIO CAGE AND A FEW SCREWS IMPLANTED BACK IN 2019. SURGEON REMOVED ALL CAGE AND SCREWS ALONG WITH A CEMENTED CUP AND REPLACED WITH A PINNACLE REVISION CUP AND USED DUAL MOBILITY TO HELP PATIENT WITH STABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 11436316 ↗InjuryJul 23, 2020Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT PATIENT PRESENTED TO DOCTOR'S OFFICE WITH PAIN. XRAYS SHOWED POSSIBLE LOOSENING OF PROTRUSIO CAGE. SURGERY SCHEDULED AND DR. (B)(6) FOUND CAGE LOOSE. REMOVED HEAD, LINER AND CAGE AND REINSERT A MULTI HOLE GRIP CUP, LINER AND HEAD. DOI: (B)(6) 2017, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.
Patient problems: Inadequate Osseointegration; No Code Available; Pain
MAUDE report 10312712 ↗InjuryJul 23, 2020Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT PATIENT PRESENTED TO DOCTOR'S OFFICE WITH PAIN. XRAYS SHOWED POSSIBLE LOOSENING OF PROTRUSIO CAGE. SURGERY SCHEDULED AND DR.K FOUND CAGE LOOSE . REMOVED HEAD, LINER AND CAGE AND REINSERT A MULTI HOLE GRIP CUP, LINER AND HEAD. DOI: (B)(6) 2017. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.
Patient problems: Inadequate Osseointegration; No Code Available; Pain
MAUDE report 10312225 ↗InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO OPERATING ROOM FOR REMOVAL OF HARDWARE DUE TO INFECTION AND ONE STAGE REVISION WAS PERFORMED WITH PLACEMENT OF ANTIBIOTIC BEADS. DOI: (B)(6) 2014; DOR: (B)(6) 2019; RIGHT HIP.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9185863 ↗InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO OPERATING ROOM FOR REMOVAL OF HARDWARE DUE TO INFECTION AND ONE STAGE REVISION WAS PERFORMED WITH PLACEMENT OF ANTIBIOTIC BEADS. DOI: (B)(6) 2014. DOR: (B)(6) 2019; RIGHT HIP.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9185841 ↗InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PFS ALLEGES INFECTION, DISLOCATION, MUSCLE DAMAGE AND ANEMIA. AFTER THE REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY,PATIENT WAS REVISED TO ADDRESS DISLOCATION,STATUS POST COMPLEX RIGHT REVISION. REVISION NOTES REPORTED OF ANTERIOR DISLOCATION. CLINICAL NOTES REPORTED OF STAPH INFECTION AND PURULENT DRAINAGE.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8239798 ↗InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8047925 ↗InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8047895 ↗InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8047856 ↗
Other Mesh, surgical, acetabular, hip, prosthesis devices
- NA 1011-40-030Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis13 reports
- NA 1011-40-025Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis13 reports
- NA 1011-40-020Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis11 reports
- NA 1011-40-040Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis11 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
- NA 1011-02-501Depuy Orthopaedics, Inc. · Mesh, surgical, acetabular, hip, prosthesis3 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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