NA 2598-07-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295148432), received between Jun 28, 2017 and Apr 21, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE STEM INSERTER TIP WAS BROKEN DURING INSERTION OF STEM. PIECE DID NOT FALL OFF DURING PROCEDURE, THEREFORE WAS NOT LEFT IN BODY. STEM WAS SUCCESSFULLY IMPLANTED WITH NO ADVERSE AFFECTS TO THE PATIENT NOR ANY TIME LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871923 ↗
• MalfunctionJan 17, 2023Break; Break

  IT WAS REPORTED THAT ONE INSTRUMENT BROKE DURING TOTAL HIP PROCEDURE, BUT WE HAD BACKUPS AVAILABLE SO THERE WERE NO DELAYS OR PROBLEMS IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16184289 ↗
• MalfunctionJan 31, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE USER FACILITY REPORT WAS RECEIVED UNDER MW5105838. PATIENT WAS PRESENTED FOR ELECTIVE TOTAL HIP ARTHROPLASTY, POST OPERATIVE X-RAYS SHOWED A RETAINED SMALL METAL PIECE WHICH WAS IDENTIFIED AS THE TIP OF AN ANTERIOR INSERTER INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392896 ↗
• MalfunctionJul 20, 2021Break; Break

  TIP OF SUMMIT CURVED IMPACTOR BROKE OFF. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195384 ↗
• MalfunctionAug 24, 2020Break; Break

  SUMMIT ANTERIOR INSERTER BROKE DURING FINAL INSERTION OF THE SUMMIT STEM. SURGICAL DELAY OF FIVE MINUTES.

  Patient problems: No Code Available

  MAUDE report 10442900 ↗
• MalfunctionAug 24, 2020Break; Break

  SUMMIT ANTERIOR INSERTER BROKE DURING FINAL INSERTION OF THE SUMMIT STEM. SURGICAL DELAY OF FIVE MINUTES.

  Patient problems: No Code Available

  MAUDE report 10442894 ↗
• MalfunctionAug 24, 2020Break; Break

  SUMMIT ANTERIOR INSERTER BROKE DURING FINAL INSERTION OF THE SUMMIT STEM. SURGICAL DELAY OF FIVE MINUTES.

  Patient problems: No Code Available

  MAUDE report 10442891 ↗
• MalfunctionAug 24, 2020Break; Break

  SUMMIT ANTERIOR INSERTER BROKE DURING FINAL INSERTION OF THE SUMMIT STEM. SURGICAL DELAY OF FIVE MINUTES.

  Patient problems: No Code Available

  MAUDE report 10442890 ↗
• MalfunctionAug 24, 2020Break; Break

  SUMMIT ANTERIOR INSERTER BROKE DURING FINAL INSERTION OF THE SUMMIT STEM. SURGICAL DELAY OF FIVE MINUTES.

  Patient problems: No Code Available

  MAUDE report 10442889 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT THE TIP OF THE SUMMIT ANTERIOR INSERTER BROKE OFF AT SOME POINT AND NEEDS TO BE REPLACED. I NOTICED IT TODAY BEFORE THIS PROCEDURE. PLEASE SEND P1 TO (B)(6). NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9078261 ↗
• MalfunctionJul 16, 2019Break; Crack; Scratched Material; Break; Crack; Scratched Material

  IT WAS REPORTED THAT THE TIP OF INSERTER BROKE AND S-ROM ADAPTOR SPLIT. EVERYTHING RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793291 ↗
• MalfunctionDec 12, 2018Break; Break

  IT WAS REPORTED THAT THE INSERTER TIP BROKE UPON IMPACTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8155371 ↗
• MalfunctionDec 10, 2018Break; Break

  IT WAS REPORTED THAT THE TIP OF INSERTER SHAFT BROKE WHILE IMPLANTING THE STEM IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8146463 ↗
• MalfunctionMar 23, 2018Break; Break

  IT WAS REPORTED THAT THE TIP OF THE MODULAR OFFSET STEM INSERTER BROKE OFF WHILE IMPACTING THE STEM. NO SURGICAL DELAY AND ALL PIECES WERE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7365146 ↗
• MalfunctionOct 20, 2017Break; Break

  IT WAS REPORTED THAT THE TIP OF THE SUMMIT ANT STEM INSERT SHAFT BROKE AS THE SURGEON ATTEMPTED TO IMPACT THE CORAIL STEM INTO THE PATIENT.

  Patient problems: No Information

  MAUDE report 6965614 ↗
• MalfunctionJun 28, 2017Break; Break

  IT WAS REPORTED THAT THE TIP OF THE STEM IMPACTOR BROKE OFF IN THE FEMORAL STEM IMPLANT. IT HAPPENED DURING IMPACTING IT INTO THE PATIENT, THE TIP BROKE OFF IN THE STEM ITSELF AND IS UNREMOVABLE AND UNMOVABLE.

  Patient problems: No Information

  MAUDE report 6673285 ↗