ATTUNE 2506-20-100Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION TIBIAL PREP TOWER · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ATTUNE knee system revision tibial prep tower is an orthopedic manual surgical instrument. The 41 reports that name its identifier describe mostly malfunctions—bent or broken pegs, posts and spikes, plus fit problems between parts—with no deaths or injuries. There are no recalls for this device. Reports fell from 7 in the prior 12 months to 2 in the most recent 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
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295436034), received between Feb 20, 2018 and Feb 19, 2026 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (19 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
- Device-Device Incompatibility19
- Material Deformation13
- Break10
- Scratched Material5
- Material Twisted/Bent4
- Difficult to Remove2
- Fitting Problem1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient17
- Insufficient Information2
- Not Applicable1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2026Material Deformation
IT WAS REPORTED THAT THE POST ON THE STEMMABLE PREP TOWER WAS BENT, WILL NO LONGER FIT THROUGH THE HOLES ON THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24392928 ↗MalfunctionJul 28, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE DEVICE WAS BENT AND UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22628475 ↗MalfunctionJul 9, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TIBIAL PREP TOWER PEGS WERE BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22457442 ↗MalfunctionApr 21, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE UNIVERSAL IMPACTOR IS BROKEN, A FEMORAL SIZER HAS THE LETTERS WORN OFF, AND A REV TIBIA TOWER HAS A BENT SPIKE ON IT. ALL WERE DISCARDED BY SPD. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878082 ↗MalfunctionJan 23, 2025Break; Break
THE TIBIAL DRIL TOWER HAD A PEG BREAK OFF WHEN SURGEONS WAS TAPPING IT IN. HE HAD IT AT AN ANGLE WHILE DOING SO BECAUSE OF EXPOSURE. THE PEG BROKE OFF BUT WAS RETRIEVED. NO OTHER FRAGMENTS WERE GENERATED AND EVERYTHING WAS REMOVED. OPENED ANOTHER PAN AND CONTINUED. SHORT 1-2 MINUTE DELAY UNTIL THE PAN WAS OPENED. PROCEDURE COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21222903 ↗MalfunctionJan 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT?- NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21104900 ↗MalfunctionDec 26, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE TIBIAL DRILL GUIDE PRONGS ARE BENT AND SO WOULD NOT FIT INTO THE TRAIL PLATE. THERE WAS NO SURGICAL DELAY OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21020964 ↗MalfunctionDec 20, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THE FIXATION PINS ON THE TIBIAL PREPARATION TOWER ARE BENT OUT OF ALIGNMENT AND THE INSTRUMENT IS UNUSABLE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20988063 ↗MalfunctionSep 12, 2024Break; Break
IT WAS REPORTED THAT THE POST BROKE OFF OF THE ATTUNE REVISION TIBIAL TOWER DURING THE CASE. IT WAS BROKEN INTO 2 PIECES. BOTH PIECES WERE RECOVERED. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20199600 ↗MalfunctionApr 9, 2024Device-Device Incompatibility; Device-Device Incompatibility
WHEN PREPARING THE TIBIA, THE ATTUNE REVISION CEMENTED CONICAL REAMER 250620103 GOT STUCK IN THE ATTUNE REVISION TIBIAL PREP TOWER. IT TOOK A FEW EXTRA MINUTES FOR THE SURGICAL TEAM TO COMPLETE THE PROCEDURE. UPON INSPECTION OF THE INSTRUMENTS AFTER THE OPERATION YOU CAN SEE THAT THE REAMER IS BURRED. THE OPERATION WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19074429 ↗MalfunctionDec 15, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN UPON INSPECTION. ATTUNE REV TIBIAL PREP TOWER WAS BENT, AND DID NOT SLIDE IN BASE PLATE.
Patient problems: Insufficient Information
MAUDE report 18335083 ↗MalfunctionMay 5, 2023Break; Break
IT WAS REPORTED THAT ONE OF THE PEGS ON THE BOTTOM OF THE DRILL BUSHING BROKE OFF. ALL OF THE PIECES WERE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16878293 ↗MalfunctionMay 3, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIAL TOWER WOULD NOT ACCEPT THE BUSHING OR THE LARGER CONE REAMER/DRILL. IT WAS UNKNOWN IF IT IS OUT OF ROUND. IT WAS UNKNOWN IF IT HAS A BUR IN IT. A MALLET WAS USED TO GET BUSHING TO SEAT. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16859383 ↗MalfunctionApr 25, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE SPIKES OF THE TIBIAL PREP TOWER BENT WHILE BEING IMPACTED INTO A TRAY TRIAL AND WILL NO LONGER FIT IN A TRAY TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16811108 ↗MalfunctionApr 20, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PRONGS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16776097 ↗MalfunctionApr 5, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIAL PREP TOWER WILL NOT GO THROUGH THE HOLES IN THE TIBIAL SIZER TRIALS. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16684148 ↗MalfunctionFeb 13, 2023Device-Device Incompatibility; Material Deformation; Scratched Material; Device-Device Incompatibility; Material Deformation; Scratched Material
IT WAS REPORTED THAT THE REVISION REAMING TOWER CHEWED UP, BURRS PREVENT BUSHING FROM SEATING SMOOTHLY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16365157 ↗MalfunctionFeb 1, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT POSTS ARE BENT ON BOTTOM OF DRILL TOWER. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16277083 ↗MalfunctionNov 17, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT BOTH TOWER AND BUSHING NO LONGER FIT TOGETHER. TOWER IS BENT AND NO LONGER FIT THE BUSHING INSIDE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15817419 ↗MalfunctionJul 25, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ATTUNE TIBIAL PREP TOWER WOULD NOT ACCEPT THE INNER TIBIAL CEMENTED REAMER BUSHING. THERE WAS NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15094459 ↗MalfunctionJul 23, 2021Break; Break
THE TIBIAL PREP TOWER HAD ONE OF THE PEGS ON THE BOTTOM BREAK OFF IN THE TIBIAL TRAY TOWER. NO OTHER PIECES WERE GENERATED AND THE BROKEN PEG WAS REMOVED. ABOUT A THREE MINUTE DELAY TOTAL.
Patient problems: Insufficient Information
MAUDE report 12221567 ↗MalfunctionApr 20, 2021Break; Break
THE LEGS AT THE BOTTOM OF THE ARTICLE BROKE OFF DURING THE OR. THIS MAKES IT IMPOSSIBLE TO SKIP UNDER THE REVISION. THIS IS DUE TO IT HITTING TOO HARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11693044 ↗MalfunctionJul 13, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED AS " ATTUNE REVISION DRILL TOWER WOULD NOT ACCEPT THE REAMER. SEEMS TO BE ¿OUT OF ROUND.¿
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10264997 ↗MalfunctionJun 16, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT BEFORE THE SURGERY, WHEN THE SALES REP AND NURSE CHECKED THE DEVICE, THEY FOUND THAT THE SPIKE POINT OF THE TIBIAL PREP TOWER (P/N: 250620100) WAS EXPANDED AND DEFORMED. THEY COULD NOT ATTACH IT TO PREP TRAY. IT WAS BEFORE STERILIZATION. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10158490 ↗MalfunctionJan 6, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE PEGS ON THE TIBIAL TOWER ARE BENT WON'T FIT INTO THE TIBIAL PREP PLATES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9553866 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page