ATTUNE 2545-00-568Recalls & reported problems
Depuy (Ireland) · ATTUNE ARTICULATION SURFACE ROTATING PLATFORM CRUCIATE RETAINING SIZE 8 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE knee implant component is used in total knee replacement surgery. The 37 reports mostly describe parts breaking or coming apart during surgery — springs and shims snapping off or breaking, and components detaching — with one injury and no deaths. One recall, started in June 2015 and closed, involved a small wire spring on the ATTUNE tibial trialing instrument that could break loose 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
- 37
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295133087), received between Jun 28, 2017 and Mar 5, 2026 — classified as 1 injury, 36 malfunctions.
The most frequently reported specific device problem is “Break” (28 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
- Jun 12, 2015Class IITerminated
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-2141-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break28
- Detachment of Device or Device Component6
- Crack4
- Component Missing2
- Device-Device Incompatibility2
- Scratched Material2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Consequences Or Impact To Patient5
- Insufficient Information4
- No Information3
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Break
IT WAS REPORTED THAT THE SPRING BROKEN OFF DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24522395 ↗MalfunctionNov 13, 2025Break; Break
IT WAS REPORTED THAT THE SPRING IS BROKEN UNDERNEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23547180 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SPRINGS SPANNED OFF OF THE ATTUNE ARTICULATION SURFACE FIXED BEARING CRUCIATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490047 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SPRINGS FELL OFF IN COUPLE OF PROCEDURES. (B)(4) IS RELATED TO (B)(4). (B)(4) IS THE MOTHER COMPLAINT. (B)(4) WERE CREATED TO CAPTURE THE ADDITIONAL IPS OF THE MOTHER COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487375 ↗MalfunctionOct 22, 2025Break; Break
IT WAS REPORTED THAT UPON SETTING UP THE CASE, THE SHIM BROKE IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23359731 ↗MalfunctionJun 27, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENT IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 22347096 ↗MalfunctionJun 18, 2025Break; Break
IT WAS REPORTED THAT ATTUNE INSTRUMENTS ARE BROKEN AND WORN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22288311 ↗MalfunctionMay 29, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA), AND THE SHIM WAS FOUND BROKEN IN SET BY THE SCRUB NURSE DURING THE PROCEDURE. ALTERNATIVE SIZED ART SURFACE WAS USED FOR TRIALING DURING THE CASE, AND NO DELAY NOR AFFECT ON PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22104409 ↗MalfunctionMay 8, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE SPACER BLOCK AND ARTICULATION SURFACE HAS SNAPPED OFF AND IS MISSING SPRINGS. THE PRODUCT DAMAGE DOCUMENTED WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21985898 ↗MalfunctionMar 11, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEM WAS BROKEN, NO LONGER ABLE TO CONNECT THE SHIMS DUE TO MISSING SPRINGS (MISSING DURING STERILISATION). THERE WAS NO DELAY TO SURGERY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21574048 ↗MalfunctionFeb 26, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE RP CR ARTICULATION SURFACE S8 BROKE IN PIECES WITH REMOVAL OF TRIALING. THERE WAS NO ADVERSE CONSEQUENCE AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470493 ↗MalfunctionSep 27, 2024Crack; Crack
IT WAS REPORTED THAT ITEM WAS CRACKED.
Patient problems: Insufficient Information
MAUDE report 20322061 ↗MalfunctionSep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING HAS COME OFF AN ARTICULATING SURFACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20247016 ↗MalfunctionMay 15, 2024Break; Break
IT WAS REPORTED THAT THE IMPACTORS STARTING TO CRACK, TAB PORTION OF DOG BONE WAS BREAKING OFF AND INSERT TRIAL TAB WAS BROKEN. THESE WERE ALL TOSSED IN THE RED BIN PRIOR TO US GETTING LOTS AND WON¿T BE RETURNED DUE TO THE SAME THING.
Patient problems: Insufficient Information
MAUDE report 19320429 ↗MalfunctionApr 1, 2024Break; Break
IT WAS REPORTED THAT WHILE TRIALING THE PEG WITH A SPRING ON THE BOTTOM OF THE CR SURFACE BROKE OFF. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011169 ↗MalfunctionJan 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE SPRING IS MISSING FROM THE ARTICULATION SURFACE TRIAL. 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 18502839 ↗MalfunctionDec 7, 2023Crack; Crack
IT WAS REPORTED THAT THE FEMORAL IMPACTOR, TIBIAL IMPACTOR AND ARTICULATION SURFACE ARE CRACKED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18282625 ↗MalfunctionNov 20, 2023Break; Crack; Break; Crack
ADDITIONAL INFORMATION RECEIVED. A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18169580 ↗MalfunctionOct 9, 2023Break; Material Deformation; Scratched Material; Break; Material Deformation; Scratched Material
IT WAS REPORTED THAT DEVICE HAS GROOVES, DENTS AND CHIPS. 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 17897938 ↗MalfunctionSep 18, 2023Break; Scratched Material; Break; Scratched Material
DEVICE WAS REPORTED TO HAVE CHIPS AND GOUGES IN IT. 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 17765135 ↗MalfunctionAug 28, 2023Break; Break
IT WAS REPORTED THAT THE ITEM IS CHIPPED. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. 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 problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17631957 ↗MalfunctionMay 10, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16905049 ↗MalfunctionMar 30, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ONE OF THE SPRING LOADED CLAMPS ON THE UNDERNEATH BROKE. THEREFORE THE SHIM IS UNABLE TO CONNECT. ALL PIECES WERE REMOVED FROM THE FIELD. IT ONLY BROKE IN TWO PIECES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16642563 ↗MalfunctionAug 23, 2022Break; Break
IT WAS REPORTED THAT THE LEFT PEG BROKE OFF OF ARTICULATING SURFACE. ALL ITEMS RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15278184 ↗MalfunctionJul 11, 2022Break; Break
IT WAS REPORTED THAT THESE INSTRUMENTS ARE BROKEN AND REQUIRE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14976933 ↗
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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