NA 9626-28-000Recalls & reported problems
Depuy (Ireland) · ACET. CUP INTRODUCER 26/28mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Marathon acetabular cup introducer is a hand-held surgical instrument used to place the cup into the hip socket. The 33 reports mostly describe the tool breaking, jamming, or its spring, pin, or screws coming loose so the handle would not release the cup. There are no deaths and no injuries, and in each case surgery continued with another tray. 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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295243519), received between Apr 11, 2018 and Aug 20, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Break” (18 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
- Break18
- Mechanical Jam6
- Device-Device Incompatibility4
- Component Missing3
- Unintended Movement3
- Naturally Worn2
- Device Slipped1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient7
- Insufficient Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2026Break
It was reported that the spring came loose and handle would not function. It was further reported that the small screw was lost during sterilization and could not be reassembled. No patient harm, alternative tray was used to complete the case. No broken parts, procedure carried out as normal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50346516 ↗MalfunctionJul 31, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THERE WAS A BROKEN MARATHON CUP INTRODUCER ¿ TRIGGER MECHANISM NO LONGER RELEASING THE CUP. THERE WAS NO PATIENT IMPACT AS A SECOND TRAY WAS ABLE TO BE OPENED TO FINISH OFF THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22675463 ↗MalfunctionJan 15, 2025Break; Break
IT WAS REPORTED THAT PRE-OPERATIVELY, IT WAS NOTED THAT THE ITEM'S SCREWS WERE BROKEN, AND THE HANDLE LEVER WON'T WORK. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21159289 ↗MalfunctionJan 15, 2025Break; Break
IT WAS REPORTED THAT PRE-OPERATIVELY, IT WAS NOTED THAT THE ITEM'S SCREWS WERE BROKEN, AND THE HANDLE LEVER WON'T WORK. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21159271 ↗MalfunctionJul 1, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
DAMAGED MARATHON CUP INSERTER, PIN MISSING FROM LEVER SO NOW UNABLE TO RELEASE THE CUP. NO DELAY TO SURGERY OR HARM TO PATIENT AS IDENTIFIED BY SSD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19644548 ↗MalfunctionJun 6, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE PIN AT THE BACK OF LEVER HANDLE HAS COME LOOSE AND MECHANISM NO LONGER WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19475353 ↗MalfunctionMay 14, 2024Break; Break
IT WAS REPORTED THAT THE INTRODUCER'S SPRING IS BROKEN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19308758 ↗MalfunctionApr 16, 2024Break; Break
DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY, IS IT BENT, CRACKED, STRIPPED, SCRATCHED, WORN OR CROSS-THREADED? IT LOOKS LIKE A SMALL BOLT OR SOMETHING IS MISSING FROM THE BACK OF THE INSTRUMENT THAT PUTS THINGS TOGETHER.
Patient problems: Insufficient Information
MAUDE report 19114691 ↗MalfunctionFeb 19, 2024Unintended Movement; Unintended Movement
METAL PART INSIDE PLASTIC SCREW LOOSENED INTRA-OP. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18734373 ↗MalfunctionFeb 1, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT TRIGGER WOULD DEPRESS, BUT WON¿T RESET AFTER IT IS PRESSED. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18621751 ↗MalfunctionSep 7, 2023Break; Break
NO IMPACT TO SURGERY OR PATIENT. FOUND WHILE IN SSD AND HAS BEEN DISPOSED OF. AS BROKEN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17698695 ↗MalfunctionMay 12, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE SCREWS IN THE TOP CORNER OF THE CEMENT CUP INTRODUCER WERE STUCK. UNABLE TO DISMANTLE FOR WASHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16920285 ↗MalfunctionMay 12, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE SCREWS IN THE TOP CORNER OF THE CEMENT CUP INTRODUCER WERE STUCK. UNABLE TO DISMANTLE FOR WASHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16920271 ↗MalfunctionMay 12, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE SCREWS IN THE TOP CORNER OF THE CEMENT CUP INTRODUCER WERE STUCK. UNABLE TO DISMANTLE FOR WASHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16920265 ↗MalfunctionMay 12, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE SCREWS IN THE TOP CORNER OF THE CEMENT CUP INTRODUCER WERE STUCK. UNABLE TO DISMANTLE FOR WASHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16919577 ↗MalfunctionMay 12, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE SCREWS IN THE TOP CORNER OF THE CEMENT CUP INTRODUCER WERE STUCK. UNABLE TO DISMANTLE FOR WASHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16919568 ↗MalfunctionDec 27, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THE CUP INTRODUCER HANDLE IS BROKEN AND WON¿T UNLOCK WHEN REMOVING THE IMPLANTS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16055524 ↗MalfunctionOct 14, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENT HAS COME BACK TO THEATRE FROM STERILE SERVICES IN TWO PIECES ¿ IT APPEARS AS THOUGH THE ¿RELEASE¿ LEVER HAS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15604879 ↗MalfunctionSep 12, 2022Material Integrity Problem; Material Integrity Problem
NON FUNCTIONING DEVICE DISCOVERED BY STERILISATION DEPARTMENT. INTERNAL SPRING SYSTEM DOESN¿T FUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15406961 ↗MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INTRODUCER WAS DAMAGED. IT DOES NOT HOLD/RELEASE THE CUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14194159 ↗MalfunctionFeb 17, 2022Break; Break
CUP INTRODUCER IS BROKEN. THE MECHANISM THAT HOLDS THE CUP IS BROKEN. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13553204 ↗MalfunctionFeb 14, 2022Break; Break
IT WAS REPORTED THAT THE CUP LINER INTRODUCER IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13525005 ↗MalfunctionFeb 4, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS FAULTY, NOT FUNCTIONING AS INTENDED. OPERATION COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13451531 ↗MalfunctionNov 9, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENT WAS NO LONGER USEABLE DUE TO WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12780666 ↗MalfunctionSep 24, 2021Break; Break
IT WAS REPORTED THAT AN ELITE INTRODUCER HANDLE WAS BROKEN. ONE OF THE 3 INTRODUCER SPIKES WAS BROKEN OFF. THERE WAS NO DELAY TO THE PROCEDURE AS THEY HAD ANOTHER KIT AVAILABLE ON THE SHELF. PRODUCT WAS AVAILABLE TO BE SENT TO THE US.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12527463 ↗
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- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
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- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
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- 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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