DURALOC 2015-24-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295082408), received between Sep 20, 2017 and May 14, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Material Deformation

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE IT WAS OBSERVED THAT THE THREADS OF THE IMPACTOR HANDLE WERE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175258 ↗
• MalfunctionMay 14, 2026Material Deformation

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE IT WAS OBSERVED THAT THE THREADS OF THE IMPACTOR HANDLE WERE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175251 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT THE DUR POLY IMPACTOR HANDLE BROKE DURING SURGERY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059593 ↗
• MalfunctionOct 6, 2023Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE'S NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887302 ↗
• MalfunctionDec 6, 2021Break; Crack; Adverse Event Without Identified Device or Use Problem; Break; Crack; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE THE DOCTOR WAS IMPACTING THE ACETABULAR PINNACLE CUP AND ALL AT ONCE THE END OF THE POSITIONER HANDLE SNAPPED. THE SURGERY ENDS SATISFACTORILY WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932723 ↗
• MalfunctionOct 1, 2021Break; Break

  EMAIL RECEIVED FROM CSSD ORTHO TECH AT (B)(6) HOSPITAL. EMAIL CONTAINS LIST OF BROKEN INSTRUMENTS THAT HAVE BEEN COLLECTED OVER THE LAST WEEK. THERE IS NO INFORMATION OR DESCRIPTION ON THE EXTENT OF THE DAMAGE OR HOW THE DAMAGE OCCURRED. ONLY PRODUCT CODES ARE PROVIDED. ALL OTHER INFORMATION WILL BE FOLLOWED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561459 ↗
• MalfunctionMar 18, 2021Unintended Movement; Unintended Movement

  NURSE REPORTED A LOOSE DURALOC CUP IMPACTOR WHICH REQUIRES REPLACEMENT (NORMAL WEAR AND TEAR). IN ADDITION, SHE REPORTED AN ATTUNE TRIAL LINER WHICH LOST ITS BALSEAL AND WHICH ALSO REQUIRES REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516447 ↗
• MalfunctionAug 25, 2020Break; Break

  DURING RTC SURGERY, WITH THE CONSIGNMENT INSTRUMENTS, AT THE MOMENT THE FINAL ACETABULAR CUP WAS POSITIONED AND IMPACTED, THE IMPACTOR HANDLE BROKE. THE SURGERY COULD BE COMPLETED WITHOUT INCONVENIENCE, SINCE THE CUP HAD BEEN PROPERLY POSITIONED. PRODUCT: D201524000. LOT: NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10449410 ↗
• MalfunctionApr 8, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THREADED TIP OF 201524000 DUR POLY IMPACTOR HANDLE HAS BROKEN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938979 ↗
• MalfunctionJul 29, 2019Break; Break

  BROKEN INSTRUMENTS WERE IN DESIGNATED BOX AT FACILITY LABELED AS "BROKEN" OR WERE FOUND IN STERILE WRAPPED SETS THAT WERE RETURNED TO THE OFFICE. NO PATIENT WAS AFFECTED. NO SURGERY WAS AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8837635 ↗
• MalfunctionJul 29, 2019Break; Break

  BROKEN INSTRUMENTS WERE IN DESIGNATED BOX AT FACILITY LABELED AS "BROKEN" OR WERE FOUND IN STERILE WRAPPED SETS THAT WERE RETURNED TO THE OFFICE. NO PATIENT WAS AFFECTED. NO SURGERY WAS AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8837619 ↗
• MalfunctionFeb 8, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE POLY IMPACTOR HANDLE - THREADS HAVE WORN OFF, NOT ALLOWING CUP TRIAL TO BE FULLY SEATED ONTO HANDLE. NOTHING WAS LEFT IN PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7250817 ↗
• MalfunctionJan 17, 2018Break; Break

  IT WAS REPORTED THAT THE PINNACLE ULTAMET METAL ON METAL LINER EXTRACTOR BROKE DURING REMOVAL OF A METAL ON METAL LINER. BOTH THE LINER REMOVER AND THE IMPACTOR HANDLE BROKE DURING THE CASE. ALL PIECES WERE RETRIEVED, NOTHING LEFT IN THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7201433 ↗
• MalfunctionSep 20, 2017Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE.

  Patient problems: No Information

  MAUDE report 6879600 ↗