DURALOC 2244-08-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 267 adverse event reports that list this exact device (DI 10603295107477), received between Jun 29, 2017 and Jun 18, 2026 — classified as 267 malfunctions.

The most frequently reported specific device problem is “Break” (107 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 267 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Mechanical Jam

  IT WAS REPORTED THAT THE MECHANISM IS JAMMING AND THE HANDLE CAN¿T BE USED ANYMORE. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553456 ↗
• MalfunctionJun 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT HANDLE WAS GETTING STUCK IN THE STAR DRIVER CUP INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484416 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS LOOSE CONNECTION. THE INSERTER FELL OFF THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163654 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT DURALOC CUP IMPACTOR HANDLE SHATTERED DURING TRIAL IMPACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031453 ↗
• MalfunctionApr 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PEGS ON DURALOC CURVED CUP IMPACTOR NO LONGER FIT WITH TIP OF THE IMPACTOR AND 54 36 NEUTRAL TRIAL LINER. INNER SCREW MECHANISM WAS STRIPPED THERE WERE NO BROKEN PIECES AND NO DELAYS OR COMPLICATIONS TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859533 ↗
• MalfunctionApr 2, 2026Break; Crack

  IT WAS REPORTED THAT THE HANDLE IS CRACKED /BROKEN. THE ISSUE WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766913 ↗
• MalfunctionMar 31, 2026Break; Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE TRYING TO USE 2X DURALOC CURVED CUP IMPACTOR DEVICES, THE END PIECES WERE VERY HARD TO REMOVE ONCE SNAPPED ONTO THE INSERTER AND EVEN BECAME STUCK ON. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746577 ↗
• MalfunctionMar 31, 2026Break; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE TRYING TO USING 2X DURALOC CURVED CUP IMPACTOR DEVICES THE END PIECES WERE VERY HARD TO REMOVE ONCE SNAPPED ONTO THE INSERTER AND EVEN BECAME STUCK ON. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746567 ↗
• MalfunctionMar 25, 2026Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE BUTTONS WERE LOOSE ON THE HANDLES. IT WAS REPORTED THAT THE DEVICE WOULD NOT CONNECT TO THE ATTACHMENT PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690904 ↗
• MalfunctionMar 25, 2026Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE BUTTONS WERE LOOSE ON THE HANDLES. IT WAS REPORTED THAT THE DEVICE WOULD NOT CONNECT TO THE ATTACHMENT PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690902 ↗
• MalfunctionMar 25, 2026Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE BUTTONS WERE LOOSE ON THE HANDLES. IT WAS REPORTED THAT THE DEVICE WOULD NOT CONNECT TO THE ATTACHMENT PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690872 ↗
• MalfunctionFeb 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY TWO REMOVABLE TIPS ON THE DURALOC CURVED CUP IMPACTORS BECAME STUCK ONTO THEIR HANDLES. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. ACTIVITY LEVEL - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293101 ↗
• MalfunctionFeb 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY TWO REMOVABLE TIPS ON THE DURALOC CURVED CUP IMPACTORS BECAME STUCK ONTO THEIR HANDLES. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. ACTIVITY LEVEL - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293098 ↗
• MalfunctionFeb 4, 2026Material Deformation

  IT WAS REPORTED THAT THE DEVICE IS CROSS THREADED. IT DID NOT HAPPEN IN SURGERY. THERE WERE NO DIRECT EFFECT FROM A CASE/ SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258755 ↗
• MalfunctionFeb 4, 2026Material Deformation

  IT WAS REPORTED THAT THE DEVICE IS CROSS THREADED. IT DID NOT HAPPEN IN SURGERY. THERE WERE NO DIRECT EFFECT FROM A CASE/ SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258751 ↗
• MalfunctionFeb 4, 2026Material Deformation

  IT WAS REPORTED THAT THE DEVICE IS CROSS THREADED. IT DID NOT HAPPEN IN SURGERY. THERE WERE NO DIRECT EFFECT FROM A CASE/ SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258746 ↗
• MalfunctionFeb 3, 2026Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS CROSS THREADED. THIS EVENT DID NOT HAPPEN IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252524 ↗
• MalfunctionFeb 3, 2026Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS CROSS THREADED. THIS EVENT DID NOT HAPPEN IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252517 ↗
• MalfunctionFeb 3, 2026Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS CROSS THREADED. THIS EVENT DID NOT HAPPEN IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252499 ↗
• MalfunctionJan 2, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT BOTH DURALOC CUP IMPACTORS HAD TIPS THAT WOULD ATTACH BUT BECAME STUCK AND COULD NOT BE REMOVED. THE ISSUE WAS DISCOVERED BEFORE SURGERY. THERE WERE NO SURGICAL DELAY AND NO PATIENT HARM. ACTIVITY LEVEL - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23949989 ↗
• MalfunctionJan 2, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT BOTH DURALOC CUP IMPACTORS HAD TIPS THAT WOULD ATTACH BUT BECAME STUCK AND COULD NOT BE REMOVED. THE ISSUE WAS DISCOVERED BEFORE SURGERY. THERE WERE NO SURGICAL DELAY AND NO PATIENT HARM. ACTIVITY LEVEL - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23949988 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS DISCOVERED THAT PRIOR TO USAGE DURING A TOTAL HIP REPLACEMENT PROCEDURE, THE THREADED TIP THAT SNAPS ONTO THE IMPACTOR HANDLE HAD BECOME STUCK AND WOULD NOT COME OFF. NO HARM WAS DONE TO THE PATIENT AND THERE WAS NO SURGICAL DELAY. ACTIVITY LEVEL - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881601 ↗
• MalfunctionDec 16, 2025Crack; Crack

  IT WAS REPORTED THAT THE HANDLES WERE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816146 ↗
• MalfunctionDec 16, 2025Crack; Crack

  IT WAS REPORTED THAT THE HANDLES WERE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815905 ↗
• MalfunctionDec 16, 2025Crack; Crack

  IT WAS REPORTED THAT THE HANDLES WERE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815895 ↗