ATTUNE 2545-00-356Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM KEEL PUNCH CEMENTED LINE TO LINE SIZE 6-8 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295445678), received between Jan 10, 2018 and Nov 22, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Device-Device Incompatibility3
- Naturally Worn1
Patient problems
- Insufficient Information3
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE 3-5 TIBIAL STOP WAS CRACKED, THE 6-8 TIBIAL PUNCH WOULD NO LONGER CONNECT TO HANDLE, AND SYMMETRICAL 0 DEGREE TIBIAL BLOCK WAS SLIGHTLY BENT NOT ALLOWING FOR PIN PLACEMENT.
Patient problems: Insufficient Information
MAUDE report 20761691 ↗MalfunctionApr 23, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE 6-8 KEEL BROACH WILL NO LONGER CONNECT TO IMPACTION HANDLE.
Patient problems: Insufficient Information
MAUDE report 19163081 ↗MalfunctionFeb 15, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE KEEL PUNCH IS STRIPPED AND NO LONGER CONNECTS TO HANDLE. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 18710099 ↗MalfunctionAug 9, 2023Break; Break
IT WAS REPORTED THAT SALES CONSULTANT OBSERVED BROKEN TEETH ON THE 6/8 CEMENTED KEEL PUNCH. IT HAS BEEN PULLED FROM THE TRAY AND NEEDS TO BE REPLACED. IT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17492885 ↗MalfunctionJun 1, 2018Break; Break
IT WAS REPORTED THAT THE KEEL PUNCH BROKE WHEN HIT UP AGAINST A SCREW IN THE JOINT. IT WAS ALSO INDICATED THAT THE HANDLE BROKE UPON IMPACTION. ALL PIECES RETRIEVED FROM THE PATIENT AND NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7560284 ↗MalfunctionJan 10, 2018Break; Break
IT WAS REPORTED THAT THE FLANGE ON THE KEEL PUNCH THAT ADAPTS TO THE UNIVERSAL HANDLE BROKE OFF. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7178033 ↗
Other PUNCH, SURGICAL devices
- SIGMA LCS HIGH PERFORMANCE 9505-02-012Depuy Orthopaedics, Inc. · PUNCH, SURGICAL85 reports
- SIGMA LCS 9505-02-018Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall10 reports
- DJO SURGICAL 801-05-040Encore Medical, L.P. · PUNCH, SURGICAL1 recall7 reports
- SIGMA LCS 9505-02-017Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall1 report
- SIGMA LCS 9505-02-016Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-021Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-020Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA HIGH PERFORMANCE 9505-02-047Depuy (Ireland) · PUNCH, SURGICAL33 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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