ATTUNE 2546-00-461Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION SLAP HAMMER ADAPTOR - IMPLANT · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295440505), received between Sep 10, 2020 and Aug 19, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Naturally Worn2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2025. THE ADAPTOR THREADS DID NOT THREAD IN ANYMORE. NOTHING WAS LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22843856 ↗MalfunctionOct 14, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THE ADAPTOR AND SEPARATOR BASE ITEMS WOULD NOT THREAD INTO ATTUNE REVISION FEMUR AS PER SURGICAL TECHNIQUE STATES. ATTUNE REVISION 6MM HEX DRIVER WOULD ALLOW ITEMS TO CONNECT; THERE IS POSSIBLE DAMAGE TO THREADS OR CONNECTION POINT WITH HEX DRIVER. THE SEPARATOR ROD GOT BENT IN THE PROCESS OF TRYING TO USE THE KIT. THE EVENT WAS MANAGED BY USING OSTEOTOMES, GIGLI SAWS AND ALTERNATIVE INSTRUMENTATION TO TRY AND REMOVE. THE PROCEDURE WAS PROLONGED BY TEN (10) MINUTES; THERE WAS NO CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20439709 ↗MalfunctionFeb 15, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THREADS STRIPPED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18712156 ↗MalfunctionSep 10, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE BROACH HANDLES WERE DISENGAGING FROM BROACH. THREADED EXTRACTOR STRIPPED THREAD UPON USE. THERE WAS A SURGICAL DELAY OF 20 MINUTES.
Patient problems: No Code Available
MAUDE report 10514803 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.