SUMMIT 1570-03-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295059561), received between Jul 12, 2018 and Sep 9, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL COMPONENTS WERE REMOVED. AN ANTIBIOTIC SPACER WAS IMPLANTED BECAUSE OF INFECTION. ORIGINAL DATE OF SURGERY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23004187 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION SURGEON PULLED IMPLANTS AND PUT SPACER IN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20270941 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY, AND THE STEM, HEAD, AND LINER WERE REMOVED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2012; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17788054 ↗
• InjuryJan 4, 2023Migration; Migration

  PATIENT WAS REVISED DUE TO A SUBSIDED CEMENT AND FEMORAL STEM. REVISED TO A RECLAIM FEMORAL STEM AND ACETABULAR POLY EXCHANGE. NO FURTHER INFORMATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16094230 ↗
• MalfunctionJul 13, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT WHEN THE NURSE OPENED THE BOX THE EDGE OF THE PEEL PACK LID WAS TORN. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10264386 ↗
• InjuryMar 18, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR FAILED RIGHT TOTAL HIP REPLACEMENT, FEMORAL LOOSENING. OPERATIVE NOTES REPORTED THAT THERE WAS NOTED TO BE LOOSENING AT THE IMPLANT CEMENT INTERFACE AND THIS WAS EASILY REMOVED SIMPLY USING A BONE TAMP. THERE WAS SOME POSTERIOR INSTABILITY. DOI: (B)(6) 2005. DOR: (B)(6) 2007; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9849606 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION. DOI: UNKNOWN; DOR: UNKNOWN; (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9342457 ↗
• InjurySep 18, 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. DEPUY CEMENT WAS USED. DOI: (B)(6) 2013, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9081115 ↗
• InjuryJul 12, 2018Malposition of Device; Malposition of Device

  PATIENT WAS REVISED FOR INCORRECT VERSION OF ORIGINAL PLACEMENT, THE PATIENT WAS UNSTABLE. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7682014 ↗