NA 1011-77-000Recalls & reported problems
Depuy Orthopaedics, Inc. · PROTRUSIO CAGE CEMENTED ACETABULAR RECONSTRUCTION 64mm OD 61mm ID RIGHT · Class 2 · Implant
Data updated Oct 18, 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 10603295000594), received between Oct 14, 2019 and Jul 23, 2020 — 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loss of Osseointegration1
Patient problems
- No Code Available2
- Inadequate Osseointegration1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 10312235 ↗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 9185894 ↗
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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