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SUMMIT 1570-13-150Recalls & reported problems

Depuy Orthopaedics, Inc. · SUMMIT FEMORAL STEM 12/14 TAPER CEMENTED SIZE 8 HI 139mm · Class 2 · Implant

Adverse event reports
6
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295060277), received between May 31, 2018 and Mar 28, 2022 — classified as 5 injuries, 1 malfunction.

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

Most reported problems

Device problems

  • Loss of or Failure to Bond3
  • Adverse Event Without Identified Device or Use Problem1
  • Difficult to Open or Remove Packaging Material1
  • Insufficient Device Problem Information1
  • Missing Information1

Patient problems

  • No Code Available3
  • Bone Fracture(s)1
  • No Clinical Signs, Symptoms or Conditions1
  • Not Applicable1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

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

  • MalfunctionMar 28, 2022Difficult to Open or Remove Packaging Material; Missing Information; Difficult to Open or Remove Packaging Material; Missing Information

    REPORT PURPOSE: PACKAGING ISSUE FOR THE IMPLANT LISTED BELOW. RECEIVED REPLENISHMENT DELIVERY # (B)(4) / SHIPPING CONTAINER # (B)(4). THE IMPLANT RECEIVED DID NOT HAVE AN OUTER IMPLANT BOX WITH LABEL OR DUST COVER. THERE IS NO OTHER ADDITIONAL EVENT INFORMATION AS THIS DOES NOT RELATE TO ANY SURGERY OR PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13928487 ↗
  • InjuryApr 1, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

    AFTER REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM, WITH PROXIMAL CEMENT LOOSENING BUT WELL FIXED DISTALLY. REVISION OPERATIVE NOTES REPORTED THAT THE STEM WAS GROSSLY LOOSE AND THERE WAS SIGNIFICANT TORN POLYETHYLENE DEBRIS IN THE HIP JOINT. DOI: (B)(6) 2016. DOR: (B)(6) 2017, RIGHT HIP.

    Patient problems: No Code Available

    MAUDE report 9911309 ↗
  • InjuryMay 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE - FEMORAL CALCAR FRACTURE EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2019; DOE: (B)(6) 2019, (RIGHT HIP).

    Patient problems: Bone Fracture(s)

    MAUDE report 8627741 ↗
  • InjuryApr 16, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

    THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE AND POSSIBLE INFECTION. RIGHT HIP.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 8518260 ↗
  • InjuryOct 26, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

    THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE.

    Patient problems: No Code Available; Pain

    MAUDE report 8009569 ↗
  • InjuryMay 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    DER STATED THAT 8 HI OFFSET CEMENTED STEM ROTATION (PMMA) BEADS FALLING OUT OF STEM, NOTICED BEFORE STEM WAS IMPLANTED AND TRIED PUTTING BACK IN BUT CEMENT WAS ALREADY HARD. SURGICAL DELAY 45 MINUTES.

    Patient problems: Not Applicable

    MAUDE report 7557601 ↗

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

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

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