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SUMMIT POROCOAT 1570-11-180Recalls & reported problems

Depuy Orthopaedics, Inc. · SUMMIT FEMORAL STEM 12/14 TAPER TAPER ED w/POROCOAT SIZE 10 HI 170mm · Class 3 · Implant

All models of SUMMIT POROCOAT (20)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295060116), received between Feb 9, 2018 and Oct 27, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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
  • Device Contaminated During Manufacture or Shipping1
  • Difficult to Open or Remove Packaging Material1
  • Inadequacy of Device Shape and/or Size1
  • Insufficient Device Problem Information1
  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Code Available2
  • Edema1
  • Foreign Body Reaction1
  • Hypersensitivity/Allergic reaction1
  • Injury1
  • Limited Mobility Of The Implanted Joint1
  • No Clinical Signs, Symptoms or Conditions1
  • Osteolysis1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 27, 2021Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

    ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WERE NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT. THERE WAS A 20-MINUTE SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12708881 ↗
  • InjuryMar 23, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    PINNACLE LITIGATION RECORDS RECEIVED ALLEGING PAIN, INSTABILITY, INJURY AND PARTIAL OR COMPLETE LOSS OF MOBILITY. DOI: (B)(6) 2009; DOR: NOT INDICATED (LEFT HIP).

    Patient problems: Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain

    MAUDE report 9865508 ↗
  • InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2005 - DOR: NONE REPORTED (LEFT HIP).

    Patient problems: Test Result

    MAUDE report 8358494 ↗
  • InjuryFeb 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    PATIENT'S BLOOD-WORK REVEALED EXCESSIVE LEVELS OF COBALT AND CHROMIUM.

    Patient problems: No Code Available

    MAUDE report 7259374 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented devices →

Sources and updates

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