NA 9626-36-000Recalls & reported problems
Depuy (Ireland) · ACET. CUP INTRODUCER 32mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy acetabular cup introducer is a surgical instrument used to place hip implant cups. The 44 reports mostly describe breakage of parts, loosening or missing screws, bent pins, and springs that no longer grip the implant, along with difficulty taking the instrument apart for cleaning. No deaths and no injuries were reported, and most reports say patients were not affected. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295243588), received between Jun 4, 2018 and Sep 10, 2025 — classified as 44 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.
Reports received per month
Most reported problems
Device problems
- Break16
- Device-Device Incompatibility15
- Mechanical Jam7
- Naturally Worn6
- Contamination /Decontamination Problem5
- Material Deformation3
- Material Twisted/Bent3
- Unintended Movement3
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Consequences Or Impact To Patient6
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE INSTRUMENT IS NOT ABLE TO BE DISASSEMBLED IT BEFORE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23020146 ↗MalfunctionJul 22, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ONE OF INSTRUMENT'S PINS WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566095 ↗MalfunctionJul 14, 2025Break; Break
IT WAS REPORTED THE INSTRUMENT BROKE FROM GENERAL USAGE. UNKNOWN SURGICAL DELAY. NO PATIENT CONSEQUENCES
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494939 ↗MalfunctionJun 10, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT DURING THE REPROCESSING OF THE INSTRUMENTS, A 32MM CUP INTRODUCER GRUB SCREW CAME LOOSE SO THE RELEASE TRIGGER WAS NO LONGER ATTACHED TO THE MAIN BODY OF THE INTRODUCER HANDLE. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22175967 ↗MalfunctionMar 4, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT ITEM NO LONGER GRIP THE CUP AS THE SPRING IS DAMAGED.
Patient problems: Insufficient Information
MAUDE report 21518345 ↗MalfunctionJul 19, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEM IS DAMAGED. THE SCREW IS DAMAGED AND WONT CLAMP ONTO IMPLANT.
Patient problems: Insufficient Information
MAUDE report 19781874 ↗MalfunctionJun 13, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT A SCREW HAS BECOME LOOSE AND CANNOT BE REATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19528186 ↗MalfunctionJun 4, 2024Break; Device-Device Incompatibility; Naturally Worn; Break; Device-Device Incompatibility; Naturally Worn
WHITE SCREW IS MISSING THREADS, A PART IS STUCK INSIDE THE INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19460132 ↗MalfunctionFeb 19, 2024Break; Contamination /Decontamination Problem; Naturally Worn; Break; Contamination /Decontamination Problem; Naturally Worn
ADDITIONAL INFORMATION RECEIVED: A. WHICH PART OF THE INSTRUMENT WAS BROKEN? -SCREW WORN DOWN B. DID IT BROKE INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY OF THE INSTRUMENT. IS IT BENT, CRACKED, STRIPPED, WORN OR CROSS THREADED? -NO, WORN C. WERE THERE ANY FRAGMENTS GENERATED? IF YES, WERE ALL THE PIECES RETRIEVED? -NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18733489 ↗MalfunctionFeb 8, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE SMALL SPRING INSIDE THE PLASTIC SCREW HAS LOOSENED. WAS SURGERY TIME EXTENDED AS A DIRECT RESULT OF INCIDENT? NO. WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE? WITH SAME LIKE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18669508 ↗MalfunctionNov 20, 2023Contamination /Decontamination Problem; Mechanical Jam; Contamination /Decontamination Problem; Mechanical Jam
IT WAS REPORTED THAT INTRODUCER HAS DAMAGED THREADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18170332 ↗MalfunctionNov 20, 2023Contamination /Decontamination Problem; Mechanical Jam; Contamination /Decontamination Problem; Mechanical Jam
IT WAS REPORTED THAT INTRODUCER HAS DAMAGED THREADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18170295 ↗MalfunctionNov 20, 2023Contamination /Decontamination Problem; Mechanical Jam; Contamination /Decontamination Problem; Mechanical Jam
IT WAS REPORTED THAT INTRODUCER HAS DAMAGED THREADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18170103 ↗MalfunctionNov 20, 2023Contamination /Decontamination Problem; Mechanical Jam; Contamination /Decontamination Problem; Mechanical Jam
IT WAS REPORTED THAT INTRODUCER HAS DAMAGED THREADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18170095 ↗MalfunctionSep 7, 2023Break; Break
IT WAS REPORTED THAT DURING THE PROCEDURE AFTER THE CUP WAS IMPLANTED, THE PIN ON THE INTRODUCER BROKE SO IT NO LONGER COULD EJECT THE IMPLANT FROM THE HANDLE. THERE WAS NO CONSEQUENCE TO THE PATIENT DUE TO THE EVENT. THE SURGERY WAS NOT PROLONGED,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17700288 ↗MalfunctionSep 1, 2023Break; Naturally Worn; Break; Naturally Worn
INSTRUMENTS BROKEN DUE TO WEAR AND TEAR.
Patient problems: Insufficient Information
MAUDE report 17669261 ↗MalfunctionAug 23, 2023Break; Break
IT WAS REPORTED THAT THE THREADS LOOSEN FROM THE PLASTIC SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17608272 ↗MalfunctionFeb 13, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE BLACK CUP SIZER IS STUCK ON THE HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16364431 ↗MalfunctionFeb 13, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE BLACK CUP SIZER IS STUCK ON THE HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16364427 ↗MalfunctionJan 19, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE HANDLE HAS BECOME STIFF WHEN THE IMPLANT IS ATTACHED AND IT IS DIFFICULT TO REMOVE THE IMPLANT WITHOUT PRYING IT OFF. THIS WAS DISCOVERED DURING PREPARATION OF THE IMPLANT AND ANOTHER HANDLE WAS OPENED IN ITS PLACE SO NO DELAY TO SURGERY AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16209241 ↗MalfunctionJan 6, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THERE ARE 3 INSTRUMENTS MISSING FROM A SET. ALL INSTRUMENTS WERE BROKEN ON A SINGLE OPERATION AND THE SURGEON JUST BINNED THEM LOCALLY. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16111960 ↗MalfunctionDec 15, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE BROKE INTO TWO OR MORE PIECES. THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15990739 ↗MalfunctionNov 9, 2022Break; Break
COMPLAINT ¿ MARATHON HANDLE NOT WORKING ¿ MECHANISM FOR THE TRIGGER HAS SHEARED OFF PATIENT IMPACT ¿ NONE, NOTICED PRIOR TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15762359 ↗MalfunctionSep 28, 2022Break; Break
MARATHON CUP INTRODUCER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15497774 ↗MalfunctionSep 9, 2022Break; Break
IT WAS REPORTED THAT THE ITEM IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15391738 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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