SUMMIT 1570-13-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295060260), received between Jun 20, 2019 and Oct 26, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (2 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

Recent adverse event reports

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

• InjuryOct 26, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2017. DATE OF REVISION: (B)(6) 2022. (RIGHT HIP). TREATMENT: REVISION; STEM, HEAD, AND LINER WERE REVISED.

  Patient problems: Fall; Pain; Synovitis; Unspecified Tissue Injury

  MAUDE report 15675273 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO FRACTURED FEMUR ON THIS RIGHT SIDE. PATIENT UNDERWENT A SUMMIT CEMENTED CONSTRUCT BACK IN 2017. SHE WAS REVISED TODAY TO A RECLAIM CONSTRUCT WITH FEMORAL STRUTS AND CABLES. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 15568774 ↗
• MalfunctionAug 9, 2021Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE FEMORAL STEM HAD A HOLE IN THE STERILE PACKAGING. ANOTHER STEM WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293495 ↗
• InjuryJun 20, 2019Use of Device Problem; Use of Device Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR FX OF GREATER TROCHANTER : MALPOSITION/NON UNION TROCHANTER. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DOI: (B)(6) 2019. DOE: (B)(6) 2019, (LEFT HIP).

  Patient problems: Bone Fracture(s)

  MAUDE report 8716322 ↗