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NA 1011-04-501Recalls & reported problems

Depuy Orthopaedics, Inc. · ROOF PILE SCREW 6.5mm x 35mm · Class 2 · Implant

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 10603295000358), received between Mar 20, 2019 and Jun 17, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Osseointegration Problem1

Patient problems

  • Adhesion(s)1
  • Discomfort1
  • Inadequate Osseointegration1
  • Limited Mobility Of The Implanted Joint1
  • Pain1
  • Scar Tissue1
  • Tissue Damage1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 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)(6)) (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 14732239 ↗
  • 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 8435640 ↗

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.