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NA 1011-07-501Recalls & reported problems

Depuy Orthopaedics, Inc. · ROOF PILE SCREW 6.5mm x 50mm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295000389), received between Jun 17, 2022 and Jun 17, 2022 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Adhesion(s)1
  • Scar Tissue1
  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PC WAS CREATED TO CAPTURE THE EVENT. (B)(4). (B)(6) 2009 OPERATIVE RECORDS INDICATE THE PATIENT RECEIVED A LEFT TOTAL HIP REVISION DUE TO SIGNIFICANT SCARRING AND GROSS INFECTION. ACETABULAR CAGE AND PROSTALAC WAS REMOVED AND IRRIGATION AND DEBRIDEMENT WAS PERFORMED. DOI: (B)(6) 2009, DOR: (B)(6) 2009 LEFT HIP.

    Patient problems: Adhesion(s); Scar Tissue; Unspecified Infection

    MAUDE report 14732235 ↗

Other Mesh, surgical, acetabular, hip, prosthesis devices

All Mesh, surgical, acetabular, hip, prosthesis devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.