ATTUNE 2545-00-543Recalls & reported problems
Depuy (Ireland) · ATTUNE ARTICULATION SURFACE ROTATING PLATFORM POSTERIOR STABLIZED SIZE 3 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy ATTUNE knee implant trial instrument used to test fit during knee replacement surgery. The 34 reports mostly describe trial parts breaking during surgery, springs coming loose or going missing, and components detaching. No deaths and no injuries were reported. There is 1 recall, which is closed; it began in June 2015 because a small wire spring coil could break free and enter the surgical site.
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
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295132837), received between Jul 12, 2017 and Sep 10, 2026 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Break” (21 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 16, 2026.
Reports received per month
Recalls naming this device
- Jun 12, 2015Terminated
Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Z-2139-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break21
- Detachment of Device or Device Component8
- Component Missing6
- Material Deformation3
- Illegible Information2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient17
- Insufficient Information2
- No Information1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724100 ↗MalfunctionSep 1, 2026Break; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50090505 ↗MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE PROCEDURE WHEN THE SPECIALIST WAS GOING TO IMPACT WITH THE FEMORAL IMPACTOR, THE BLOW HE GAVE WITH THE HAMMER, THE DEVICE BROKE. IMMEDIATE SOLUTION WAS TO GIVE THE SPECIALIST ANOTHER IMPACTOR OF THE SAME CHARACTERISTICS. IN ADDITION TO THIS DURING THE PROCEDURE IT IS EVIDENT THAT THE TEST INSERTS OF 3 AND 4 REF AND REF DO NOT HAVE THE SPRINGS BUT OF THESE IT WAS NOT NECESSARY TO USE DURING THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21968676 ↗MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TRIALS HAD ONE MISSING SPRING. IT WAS POINTED OUT BY THE STERILE PROCESSING DEPARTMENT AFTER THE CASE. IT WAS UNKNOWN IF THEY CAME OFF IN SURGERY OR WHILE BEING WASHED. THESE WERE USED MULTIPLE TIMES THROUGHOUT THE WEEK BUT IT WAS JUST NOTICED THAT THESE WERE MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20383814 ↗MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TRIALS HAD ONE MISSING SPRING. IT WAS POINTED OUT BY THE STERILE PROCESSING DEPARTMENT AFTER THE CASE. IT WAS UNKNOWN IF THEY CAME OFF IN SURGERY OR WHILE BEING WASHED. THESE WERE USED MULTIPLE TIMES THROUGHOUT THE WEEK BUT IT WAS JUST NOTICED THAT THESE WERE MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20383589 ↗MalfunctionJun 26, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: NO HOSPITAL WAS INVOLVED. THESE WERE FOUND IN A FIELD SALES OFFICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19613406 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19085329 ↗MalfunctionFeb 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING IS MISSING FROM ARTIC SURFACE. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST: TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18660021 ↗MalfunctionNov 29, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18226669 ↗MalfunctionDec 29, 2021Device-Device Incompatibility; Device-Device Incompatibility
THE TIBIAL IMPACTOR IS CRACKED. PAINT IS MISSING FROM THE FEMORAL SIZER. SURFACE TRIAL WILL NOT CONNECT TO THE SHIM PROPERLY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13112860 ↗MalfunctionNov 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE CONFERENCE OF THE MODULE PK20132N, THE INSPECTION TEAM FROM LOCAL DC DETECTED THE LACK OF SPRINGS IN THE DEVICES. DATE OF EVENT: (B)(6) 2021. PLEASE VERIFY IF THE PRODUCT IS AVAILABLE FOR RETURN OR NOT? YES, ALREADY RETURNED ON NOV 11, 2021."
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12838248 ↗MalfunctionNov 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE CONFERENCE OF THE MODULE PK20132N B10, INSPECTION TEAM DETECTED THE LACK OF SPRINGS IN THE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12780934 ↗MalfunctionAug 20, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TKA SURGERY FOR OSTEOARTHRITIS OF RIGHT KNEE. WHEN THE SURGEON INSERTED THE TRIAL INSERT, THE SPRING ON THE LOWER SURFACE OF THE TRIAL INSERT BROKE. THE PLASTIC PART OF THE TRIAL INSERT CRACKED AND THE SPRING PART CAME OFF. NO FRAGMENTS OF THE BREAKAGE WERE LEFT IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY.
Patient problems: Insufficient Information
MAUDE report 12347623 ↗MalfunctionAug 18, 2021Break; Crack; Break; Crack
IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN, USED IN SURGERY AND THE SURGERY TIME WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12339114 ↗MalfunctionJun 1, 2021Break; Break
IT WAS REPORTED THAT THE SHIM AND RP PLATFORM BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11914306 ↗MalfunctionMay 20, 2021Break; Break
IT WAS REPORTED THAT THE SZ 3 RP PS TRIAL CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11859814 ↗MalfunctionDec 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CENTRAL STERILE PROCESSING STAFF FOUND A LOOSE SPRING ON THE BOTTOM LEFT SURFACE OF AN ATTUNE SIZE 3RP ARTIC SURF TRIAL. THIS INCIDENT DID NOT OCCUR DURING SURGERY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10978741 ↗MalfunctionDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SPRING COMPONENT WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10960598 ↗MalfunctionJul 16, 2020Break; Break
HANDED A BROKEN ATTUNE ARTICULATING SURFACE ROTATING PLATFORM SIZE 3 SHIM FROM THE BIOMEDICAL ENGINEERING / CSSD DEPARTMENT. DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4) DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283772 ↗MalfunctionApr 17, 2020Break; Illegible Information; Break; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN OR SIZES CAN¿T BE READ ANYMORE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9972733 ↗MalfunctionApr 17, 2020Break; Illegible Information; Break; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN OR SIZES CAN¿T BE READ ANYMORE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9972732 ↗MalfunctionMar 2, 2020Break; Break
IT WAS REPORTED THAT WHILE EXAMINING THE INSTRUMENTS THE FEMORAL TRIAL PS RP SIZE 3 WAS CHIPPED ON THE ANTERIOR SIDE NEAR THE GRAY DOT. THIS WAS NOT USED IN SURGERY. SURGERY WAS NOT DELAYED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9776794 ↗MalfunctionDec 6, 2019Component Missing; Contamination /Decontamination Problem; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Component Missing; Contamination /Decontamination Problem; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SEVERAL INSTRUMENTS WERE DISCOVERED TO BE DAMAGED DURING THE DECONTAMINATION PROCESS BY REPROCESSING STAFF. THE ATTUNE FEMORAL IMPACTOR ATTACHMENT HAS A CRACKED ON THE TOP SURFACE. SIZE 3 ATTUNE RP PS ARTIC SURF HAD A SPRING COME OFF WHILE BEING CLEANED. SIZE 6 ATTUNE RP PS ARTIC SURF ALSO HAD A SPRING COME OFF WHILE BEING REPROCESSED. THERE WERE NO PATIENTS INVOLVED IN THE INCIDENTS. SURGERY TIME WAS NOT EXTENDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9432361 ↗MalfunctionOct 1, 2019Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN DURING CASE. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9142060 ↗MalfunctionMay 3, 2019Break; Break
IT WAS REPORTED THAT THE PEG BROKE OFF OF A SZ 3 ATTUNE RP PS ARTIC SURFACE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8579535 ↗
Other TEMPLATE devices
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- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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