ATTUNE 2544-00-525Recalls & reported problems
Depuy (Ireland) · ATTUNE MEASURED SIZING AND ROTATION GUIDE · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This DePuy Attune sizing guide is a measuring tool used to size and rotate knee implants. Its 183 reports include no deaths and 1 injury. Many describe the guide breaking, cracking, jamming, or measuring incorrectly. There is 1 open recall, started in June 2022, over a spring that may corrode and leave debris in the surgical field.
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
- 187
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 187 adverse event reports that list this exact device (DI 10603295434061), received between Dec 2, 2017 and Sep 16, 2026 — classified as 1 injury, 186 malfunctions.
The most frequently reported specific device problem is “Break” (92 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
- Jun 29, 2022Class IIOpen, Classified
Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain
Z-1419-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break92
- Mechanical Jam26
- Device-Device Incompatibility16
- Crack15
- Incorrect Measurement14
- Material Deformation10
- No Apparent Adverse Event8
- Physical Resistance/Sticking4
Patient problems
- No Clinical Signs, Symptoms or Conditions127
- No Consequences Or Impact To Patient32
- Insufficient Information27
- No Code Available4
- Not Applicable2
Recent adverse event reports
The 25 most recent of 187 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Break
It was reported that the spring of the measured resection guide broke off intra op.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793865 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721636 ↗MalfunctionSep 1, 2026Break
It was reported that the nurse had dropped the sizer and it had broke. A replacement was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551495 ↗MalfunctionAug 31, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531557 ↗MalfunctionAug 31, 2026Break; Crack
It was reported that during a Total Knee Arthroplasty surgery the femoral size cracked. One piece of plastic broke off and was recovered. The surgery was not delayed. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525715 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459273 ↗MalfunctionAug 12, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50224841 ↗MalfunctionJun 2, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT SIZER CENTER WAS BENT AND WOULD NOT SLIDE FREELY. IT WAS REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364916 ↗MalfunctionJun 2, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT SIZER CENTER WAS BENT AND WOULD NOT SLIDE FREELY. IT WAS REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364915 ↗MalfunctionJun 1, 2026Mechanical Jam
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE SIZER WAS TOUGH TO SLIDE UP AND DOWN. THE REPORTER WAS KEEPING IT UNTIL A NEW ONE COMES IN TO KEEP THE SET COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355253 ↗MalfunctionMay 19, 2026Structural Problem
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE SIZER DID NOT LOCK AT THE DESIRED ROTATION. THERE WERE NO DELAYS, AND NOTHING WAS LEFT IN THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219010 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS HAVE BEEN BROKEN OVER TIME. THEY WERE NOT USED, THERE WAS NO DELAY TO SURGERY, AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780675 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS HAVE BEEN BROKEN OVER TIME. THEY WERE NOT USED, THERE WAS NO DELAY TO SURGERY, AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780674 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS HAVE BEEN BROKEN OVER TIME. THEY WERE NOT USED, THERE WAS NO DELAY TO SURGERY, AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780657 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE SIZER ROTATION ADJUSTMENT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775960 ↗MalfunctionMar 16, 2026Mechanical Jam
IT WAS REPORTED THAT THE SIZING GUIDE WAS NOT TELESCOPING UP AND DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604561 ↗MalfunctionMar 9, 2026Break
IT WAS REPORTED THAT TWO (2) ATTUNE MES SIZING/ROT GDE BROKE SEQUENTIALLY IN THE SAME CASE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24548889 ↗MalfunctionMar 9, 2026Break
IT WAS REPORTED THAT TWO (2) ATTUNE MES SIZING/ROT GDE BROKE SEQUENTIALLY IN THE SAME CASE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24548880 ↗MalfunctionMar 5, 2026Break
IT WAS REPORTED THAT INSTRUMENT BROKE WHILE USING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524270 ↗MalfunctionMar 4, 2026Mechanical Jam
IT WAS REPORTED THAT ATTUNE MES SIZING/ROT GDE HAD A FUNCTIONAL ISSUE WHERE THE FEMORAL COMPONENT METER BECAME STUCK AND REQUIRED SIGNIFICANT FORCE TO MEASURE THE FEMUR. THE EVENT DID NOT IMPAIR THE SURGICAL PROCEDURE, WHICH WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24511801 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE SPRING WAS BROKEN AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497092 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE SPRING WAS BROKEN AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497091 ↗MalfunctionFeb 13, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT SURGERY WITH THE PRODUCT IN QUESTION. DURING THE SURGERY, THE PRODUCT BROKE. NO RESIDUAL MATERIAL REMAINED IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE DETAILS ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333488 ↗MalfunctionFeb 11, 2026Break
IT WAS REPORTED THAT DURING THE CASE, PART OF THE DEVICE BROKE MAKING THE MECHANISM OF CHANGING THE DEGREES OF ROTATION UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312489 ↗MalfunctionJan 27, 2026Device-Device Incompatibility
IT WAS REPORTED THAT ATTUNE FEMORAL SIZER WILL NO LONGER ACCEPT STYLUS, SO CAN'T SIZE FEMUR ACCURATELY. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193071 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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