ATTUNE 2545-00-366Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM FEMORAL TRIAL GRIPPER · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE femoral trial gripper is a surgical template used to size and position the femoral part of a knee replacement during surgery. The 30 reports mostly describe the plastic gripper breaking, jamming, or being difficult to open and close, with stripped threads and a handle that broke while the surgeon was removing the trial femur. No deaths or injuries were reported, and no recalls name this device. Reports rose from 3 in the previous 12 months to 11 in the last 12 months.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295445241), received between Sep 6, 2019 and Sep 29, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Break” (17 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break17
- Device-Device Incompatibility13
- Mechanical Jam5
- Difficult to Open or Close3
- Material Deformation3
- Structural Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information12
- No Consequences Or Impact To Patient5
- No Code Available2
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Structural Problem; Device-Device Incompatibility
It was reported that the femoral gripper would not release. There was no delay to the procedure. There was no harm to patient. No additional information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937997 ↗MalfunctionMar 11, 2026Mechanical Jam
IT WAS REPORTED THAT THE FEMORAL GRIPPER WAS GETTING STUCK IN THE CLOSED POSITION. IT NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567775 ↗MalfunctionFeb 9, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE THREADS STRIPPED ON THE PRESSFIT PATELLA CLAMP, AND TRIAL GRIPPER FEMORAL.
Patient problems: Insufficient Information
MAUDE report 24292630 ↗MalfunctionFeb 9, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE THREADS STRIPPED ON THE PRESSFIT PATELLA CLAMP, AND TRIAL GRIPPER FEMORAL.
Patient problems: Insufficient Information
MAUDE report 24292629 ↗MalfunctionFeb 9, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE THREADS STRIPPED ON THE PRESSFIT PATELLA CLAMP, AND TRIAL GRIPPER FEMORAL.
Patient problems: Insufficient Information
MAUDE report 24292628 ↗MalfunctionDec 11, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA), THE HANDLE BROKE WHILE TRYING TO TAKE THE FEMUR OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23783654 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555652 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555646 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555643 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555641 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555640 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555637 ↗MalfunctionMay 21, 2025Break; Break
IT WAS REPORTED THAT THE GRIPPER TIP WELD HAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22062683 ↗MalfunctionMay 6, 2025Device-Device Incompatibility; Difficult to Open or Close; Device-Device Incompatibility; Difficult to Open or Close
IT WAS REPORTED THAT THE LEVER OF THE FEMORAL GRIPPER IS CATCHING AND WILL NOT CLOSE AND OPEN CORRECTLY. IT WAS CAUSING THE FEMUR TO GET STUCK. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21969858 ↗MalfunctionJan 24, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE FEMORAL TRIAL EXTRACTOR IS JAMMED SHUT.
Patient problems: Insufficient Information
MAUDE report 21233605 ↗MalfunctionSep 16, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PRIMARY TOTAL KNEE REPLACEMENT, THE SURGEON NOTED THAT THE FEMORAL TRIAL GRIPPER WOULD NOT CONNECT TO THE FEMORAL TRIAL. THERE WERE NO BROKEN PIECES. THERE WAS NO DELAY OR COMPLICATION TO THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 20225460 ↗MalfunctionSep 16, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A PRIMARY TOTAL KNEE REPLACEMENT, THE SCRUB TECH NOTED THAT THE FEMORAL TRIAL GRIPPER WAS DENTED SUCH THAT IT COULD NOT GRAB THE FEMORAL TRIALS. THERE WERE NO BROKEN PIECES. THERE WAS NO DELAY OR COMPLICATION TO THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 20224199 ↗MalfunctionJun 5, 2024Break; Break
IT WAS REPORTED THAT FEMORAL REMOVER SPRINGS ARE BUSTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19469290 ↗MalfunctionApr 30, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE FEMORAL GRIPPER WILL NO LONGER SQUEEZE.
Patient problems: Insufficient Information
MAUDE report 19217257 ↗MalfunctionApr 30, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE FEMORAL GRIPPER WILL NO LONGER SQUEEZE.
Patient problems: Insufficient Information
MAUDE report 19217252 ↗MalfunctionApr 30, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE PEG ON THE FEMORAL GRIPPER BROKE OFF, UNABLE TO HOLD A FEMORAL TRIAL ANYMORE. SURGICAL DELAY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19217203 ↗MalfunctionApr 30, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE PEG ON THE FEMORAL GRIPPER BROKE OFF, UNABLE TO HOLD A FEMORAL TRIAL ANYMORE. SURGICAL DELAY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19217200 ↗MalfunctionOct 19, 2023Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE HOLDER DEVICE WAS LOCKED CLOSED AND WOULD NOT OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17965381 ↗MalfunctionOct 19, 2023Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE HOLDER DEVICE WAS LOCKED CLOSED AND WOULD NOT OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17965345 ↗MalfunctionApr 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE PRIMARY TOTAL KNEE ARTHROPLASTY, THE SURGEON NOTED THAT THE FEMORAL EXTRACTOR WOULD NOT PROPERLY CONNECT TO THE FEMUR TRIALS. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16794502 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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