ATTUNE 2545-00-173Recalls & reported problems
Depuy (Ireland) · ATTUNE KEEL PUNCH SIZE 3-5 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295416036), received between Jul 10, 2019 and Mar 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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
- Device-Device Incompatibility1
- Material Deformation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
ATTUNE TIBIAL KEEL PUNCH DAMAGED. PATIENT IMPACT ¿ NONE ¿ WAS NOTICED PRE OP AND SECOND SET OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18839799 ↗MalfunctionJul 10, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ONCE THE REVISION SURGERY WAS COMPLETED (IT¿S REPORTED AS (B)(4)). IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO CHECK EXTENSION AND FLEXION OF THE PATIENT'S KNEE JOINT DURING THE REVISION SURGERY ON (B)(6) 2019 BY USING THE TIBIAL INSERT TRIAL (P/N: 251700406) WITH THE INSTRUMENTS WHICH WERE COMBINED WITH THE EVALUATION BULLET NO SPIKE (P/N: 254500127) AND THE KEEL PUNCH (P/N: 254500173), HOWEVER THE SHAPE OF THE TIBIAL INSERT TRIAL DID NOT FIT WITH THE INSTRUMENTS AND DID NOT ENGAGED. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8775884 ↗
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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