NA 9626-00-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295243267), received between Sep 8, 2017 and May 16, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE HANDLE IS NOT GRIPPING THE IMPLANT CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19337969 ↗
• MalfunctionMay 16, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE HANDLE IS NOT GRIPPING THE IMPLANT CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19337962 ↗
• MalfunctionDec 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THE CUP NO LONGER RELEASES CORRECTLY. ALTERNATIVE USED. NO DELAY TO SURGERY OR PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983130 ↗
• MalfunctionJul 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DURING CUP IMPLANTATION, THE INTRODUCER DIDN¿T RELEASE THE CUP AFTER IMPLANTING. AFTER A TWO MINUTE DELAY, THE CUP WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 12233046 ↗
• MalfunctionJul 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INTRODUCER WOULDN¿T DETACH WHEN INSERTING THE CUP. SURGICAL DELAY OF 2 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211077 ↗
• MalfunctionMay 13, 2021Material Twisted/Bent; Material Twisted/Bent

  WORN INSTRUMENTS IDENTIFIED BY STERILISATION. NO REPORTED SURGICAL DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821629 ↗
• MalfunctionAug 19, 2020Break; Break

  MARATHON CEMENTED CUP IMPACTORS, TWO ARE VERY LOOSE (28 & 32 HANDLES) AND THE OTHER HANDLE (36 HANDLE) HAS BROKEN INTO A COUPLE OF PIECES. PIECES CAME APART WHEN CLEANING AND THE OTHER HANDLE WAS NOTICED IN CSSD THAT IT WAS LOOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10428037 ↗
• MalfunctionAug 6, 2020Crack; Crack

  EVENT DESCRIPTION OF COMPLAINT (PLEASE SUPPLY SPECIFIC DETAILS): CRACK IN A PLASTIC PART INSIDE THE INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10373363 ↗
• MalfunctionJul 14, 2020Naturally Worn; Naturally Worn

  THIS IS A INSTRUMENT WHICH IN NORWAY NEEDS TO BE DISSEMBLED. THERE IS A PLASTIC PART INSIDE WHICH WEAR OUT AND NEEDS TO BE REPLACED. WITH SPAREPARTS THIS COULD BE SOLVED WITHOUT WRITHING COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10272098 ↗
• MalfunctionJun 30, 2020Device-Device Incompatibility; Device-Device Incompatibility

  HANDLE DOESN¿T RELEASE LINER APPROPRIATELY. TRIGGER NOT WORKING. NOTICED AT STERILIZATION PROCESS, UNKNOWN HOW THE EVENT WAS MANAGED. NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213398 ↗
• MalfunctionSep 21, 2018Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  TRIGGER PIVOT PIN HAS COME OUT OF THE INTRODUCER HANDLE. "THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7897839 ↗
• MalfunctionSep 21, 2018Break; Break

  TRIGGER PIVOT SCREWS HAVE COME OUT OF INTRODUCER BODY. RENDERING THESE INSTRUMENTS UNUSABLE. "THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7897592 ↗
• MalfunctionSep 8, 2017Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT ITEM DISCOVERED TO BE MISSING A SMALL LUG SCREW BY THE ORTHO TECHNICIAN WHEN PACKING THE SET AFTER BEING WASHED AND STERILISED. IT WAS ASSUMED THAT SCREW HAS WORKED LOOSE AND FALLEN OUT IN THE WASHING / STERILISATION PROCESS.

  Patient problems: No Information

  MAUDE report 6851574 ↗