SUMMIT 2570-00-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295142904), received between Sep 13, 2018 and Mar 22, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2021Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE BROACHES WERE WORN FROM NORMAL USE THEY WERE NOT REMOVING ENOUGH BONE THEN CAUSING THE IMPLANT TO SIT PROUD A BIT. SURGERY WASN¿T DELAYED AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541715 ↗
• MalfunctionMar 22, 2021Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE BROACHES WERE WORN FROM NORMAL USE THEY WERE NOT REMOVING ENOUGH BONE THEN CAUSING THE IMPLANT TO SIT PROUD A BIT. SURGERY WASN'T DELAYED AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541622 ↗
• MalfunctionMay 26, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE BROACH WAS STRIPPED AND WAS NEVER IMPLANTED IN THE PATIENT. ALSO, THERE WERE NO BROKEN PIECES OFF THE INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10087860 ↗
• MalfunctionMar 23, 2020Dull, Blunt; Material Twisted/Bent; Illegible Information; Dull, Blunt; Material Twisted/Bent; Illegible Information

  SIZE ETCHINGS ARE WORN AND NOT LEGIBLE, AND EDGES ARE DULL AND NOT ADEQUATE IN CUTTING BONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9867897 ↗
• MalfunctionMar 23, 2020Dull, Blunt; Material Twisted/Bent; Illegible Information; Dull, Blunt; Material Twisted/Bent; Illegible Information

  SIZE ETCHINGS ARE WORN AND NOT LEGIBLE, AND EDGES ARE DULL AND NOT ADEQUATE IN CUTTING BONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9867891 ↗
• MalfunctionAug 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT DURING THE PRIMARY SURGERY, THE SIZE 3 SUMMIT STEM WAS FOUND TO BE 1-2 MM MORE PROUD THAN THE BROACH. WHEN THE STEM INSERTER WAS REMOVED, IT WAS QUITE TIGHT WITHIN THE FEMORAL STEM AND AS THIS WAS BEING WIGGLED BACK AND FORTH TO BE REMOVED, A SMALL LONGITUDINAL UNICORTICAL FRACTURE OF THE GREATER TROCHANTER OCCURRED. DOE: (B)(6) 2008.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8922746 ↗
• MalfunctionSep 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 3 BROACH NOT ATTACHING AND RELEASING FROM BROACH HANDLE EASILY. NO FURTHER INFO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872252 ↗