ATTUNE 2544-01-004Recalls & reported problems
Depuy (Ireland) · ATTUNE TIBIAL IMPACTOR ROTATING PLATFORM · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune tibial impactor appears in 874 adverse event reports, with no deaths and no injuries. Most describe the impactor breaking or cracking during surgery, and some note all pieces were retrieved. One closed recall, started in November 2014, concerns impactors that broke into small pieces that could stay in a patient if not seen during surgery.
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
- 875
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 875 adverse event reports that list this exact device (DI 10603295130208), received between Jun 22, 2017 and Sep 28, 2026 — classified as 875 malfunctions.
The most frequently reported specific device problem is “Break” (770 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Nov 10, 2014Class IITerminated
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Z-0904-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break770
- Crack163
- Naturally Worn23
- Scratched Material12
- No Apparent Adverse Event10
- Material Twisted/Bent8
- Material Integrity Problem7
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions517
- No Consequences Or Impact To Patient300
- Insufficient Information35
- No Information25
- No Code Available11
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 875 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break; Crack
It was reported that the femoral and rotating platform (RP) tibia impactors were cracked and breaking.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913099 ↗MalfunctionSep 25, 2026Break
It was reported that a small post from the Black RP impactor tip broke off during implantation. The broken piece was retrieved from the field, but it was inadvertently thrown away. The remainder of the impactor was removed from the field. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898054 ↗MalfunctionAug 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260945 ↗MalfunctionJul 2, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY THE RP IMPACTOR BROKE DURING IMPACTION AND NEEDED REPLACEMENT. THE 14 MM AND 16 MM SHIMS HAD CRACKS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25690190 ↗MalfunctionJun 30, 2026Crack
IT WAS REPORTED THAT THE IMPACTOR TIP CRACKED. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25666148 ↗MalfunctionJun 25, 2026Break
IT WAS REPORTED THAT THE RP TIBIAL IMPACTOR DEVICE BROKE. ALL FRAGMENTS WERE RETRIEVED. NO TIME WAS ADDED TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627576 ↗MalfunctionJun 2, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN THE SURGEON WAS IMPACTING THE TIBIAL IMPLANT, IT WAS OBSERVED THAT THE IMPACTOR TIP WAS BROKE. ALL PIECES WERE RETRIEVED. NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25365292 ↗MalfunctionApr 8, 2026Break
IT WAS REPORTED THAT TIBIAL IMPACTOR BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24822440 ↗MalfunctionApr 8, 2026Break; Crack
IT WAS REPORTED THAT THE TIBIAL IMPACTOR WAS CRACKED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818360 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE IMPACTOR WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775186 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT THERE WERE BROKEN AND WORN ATTUNE FB AND RP IMPACTORS. THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752578 ↗MalfunctionMar 9, 2026Break
IT WAS REPORTED THAT THE TIBIAL RP IMPACTOR WAS BROKEN UPON IMPACTING THE FINAL TIBIAL IMPLANT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551481 ↗MalfunctionMar 2, 2026Break
IT WAS REPORTED THAT ATTUNE RP IMPACTOR BROKE DURING A TOTAL KNEE ARTHROPLASTY SURGERY. THE PLASTIC ATTUNE RP TIBIAL IMPACTOR SPLIT INTO FIVE PIECES DURING THE IMPACTION OF THE ATTUNE TIBIAL BASE PLATE. ALL BUT ONE TINY PIECE OF THE IMPACTOR WERE FOUND. THE CASE WAS NOT DELAYED SINCE THE IMPLANT WAS FULLY SEATED WHEN THE IMPACTOR BROKE. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489517 ↗MalfunctionMar 2, 2026Break; Crack
IT WAS REPORTED THAT RP IMPACTOR BROKE WHILE BEING INSPECTED BY STERILE PROCESSING STAFF. THEY SAID THERE WAS A CRACK THEY WERE INSPECTING WHEN THE IMPACTOR BROKE COMPLETELY IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24485030 ↗MalfunctionFeb 17, 2026Break
IT WAS REPORTED THAT THE IMPACTOR BROKE WHILE IMPACTING THE TIBIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367405 ↗MalfunctionFeb 13, 2026Break
IT WAS REPORTED THAT THE IMPACTOR WAS NOTICED TO BE BROKEN UPON TRAY ASSEMBLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332558 ↗MalfunctionFeb 9, 2026No Apparent Adverse Event
THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE ATTUNE RP TIBIAL IMPACTOR IS CRACKED IN THE MIDDLE SECTION. ADDITIONALLY, THE DEVICE SHOWS A SMALL BROKEN FRAGMENT THAT WAS NOT RETURNED ALONG WITH THE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291872 ↗MalfunctionFeb 6, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TIP OF THE RP TIBIAL IMPACTOR DEVICE WAS BROKEN. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278285 ↗MalfunctionFeb 3, 2026Break; Crack
IT WAS REPORTED THAT WHILE REASSEMBLING AND INSPECTING INSTRUMENTS AFTER SURGERY, I FOUND SEVERAL CRACKED AND BROKEN INSTRUMENTS. INSTRUMENTS WERE NOT CRACKED OR BROKEN DURING SURGERY. NO DELAYS. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248432 ↗MalfunctionJan 21, 2026Break
IT WAS REPORTED THAT WHILE IMPACTING THE TRAY THE PLASTIC IMPACTOR BROKE. THERE WAS NO PATIENT HARM, AND NO PROCEDURAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24134607 ↗MalfunctionJan 20, 2026Break
IT WAS REPORTED THE DEVICES WERE FOUND BROKEN DURING ROUTINE INSPECTION AT THE FIELD OFFICE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24115866 ↗MalfunctionDec 17, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT ARTIFICIAL KNEE REPLACEMENT FOR KNEE OSTEOARTHRITIS USING RP IMPACTORS. DURING THE TIBIA IMPACTION, THE IMPACTORS BROKE. THE DEVICES WERE REMOVED FROM USE AND THE FRAGMENT RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826847 ↗MalfunctionDec 10, 2025Break; Break
IT WAS REPORTED THAT DURING A RIGHT TOTAL KNEE SURGICAL PROCEDURE, DURING IMPACTION OF THE TIBIAL TRAY AND FEMUR, THE TIBIAL AND FEMORAL IMPACTORS BROKE INTO MULTIPLE PIECES. ALL PIECES WERE FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772100 ↗MalfunctionDec 4, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA), A BROKEN RP TIBIA IMPACTOR WAS OBSERVED; ALL PIECES WERE RECOVERED, THERE WAS NO SURGICAL DELAY, AND THE DEVICE WAS REMOVED FROM THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717866 ↗MalfunctionNov 21, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT DURING IMPACTION OF THE TIBIAL TRAY, THE IMPACTOR WAS CRACKED. ALL PIECES WERE PRESENT (REMOVED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617210 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
- SELF CENTERING 2055-13-000Depuy (Ireland) · IMPACTOR324 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 · each recall links to the FDA recall notice
- 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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