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SUMMIT 1570-03-135Recalls & reported problems

Depuy Orthopaedics, Inc. · SUMMIT FEMORAL STEM 12/14 TAPER CEMENTED SIZE 7 STD 133mm · Class 2 · Implant

All models of SUMMIT (53)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295059578), received between Oct 9, 2018 and Feb 1, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 Problem3
  • Loss of or Failure to Bond3

Patient problems

  • No Code Available5
  • Pain2
  • Unspecified Infection2
  • Insufficient Information1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 1, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

    IT WAS REPORTED THAT FEMORAL STEM BECAME LOOSE IN CEMENT TO IMPLANT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

    Patient problems: Insufficient Information

    MAUDE report 16277125 ↗
  • InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PAINFUL, INFECTED HIP. WE REMOVED HER PROSTHESIS IN ORDER TO TREAT HER INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: UNKNOWN.

    Patient problems: No Code Available; Pain; Unspecified Infection

    MAUDE report 10524715 ↗
  • InjuryMar 27, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

    IT WAS REPORTED THAT THE PATIENT HAD DISLOCATION ISSUES, AFTER INCISION THE DOCTOR FOUND THE STEM TO BE LOOSE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020, AFFECTED SITE: LEFT HIP.

    Patient problems: No Code Available

    MAUDE report 9890136 ↗
  • InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION DUE TO INFECTION.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 9342706 ↗
  • InjuryJul 9, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SUMMIT CEMENTED CONSTRUCT SEVERAL YEARS AGO. UNFORTUNATELY, IT WAS FOUND THAT THE STEM WAS INDEED LOOSE AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO INDICATED THAT IT IS UNSURE EXACTLY WHAT CAUSED THIS LOOSENING. THE PATIENT WAS REVISED TO A RECLAIM CONSTRUCT. DOI: (B)(6) 2014. DOR: JUNE 18, 2019. RIGHT HIP.

    Patient problems: No Code Available

    MAUDE report 8771075 ↗
  • InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS REVISED TO ADDRESS HIP PAIN.

    Patient problems: No Code Available; Pain

    MAUDE report 7946398 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources and updates

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