ATTUNE 2545-00-565Recalls & reported problems
Depuy (Ireland) · ATTUNE ARTICULATION SURFACE ROTATING PLATFORM CRUCIATE RETAINING SIZE 5 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE rotating platform knee implant surface is used in total knee replacement surgery. Most of the 63 reports describe trial components breaking, springs coming loose or missing, or parts detaching during surgery — often found by sterile processing staff before or during a case, with no reported effect on the patient. There are no deaths and no injuries. One recall, started in June 2015 and closed, concerned a small wire spring coil on the trial instruments that could come 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
- 64
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10603295133056), received between Jul 13, 2017 and Sep 21, 2026 — classified as 64 malfunctions.
The most frequently reported specific device problem is “Break” (45 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-2141-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break45
- Detachment of Device or Device Component13
- Component Missing3
- Material Deformation3
- Scratched Material3
- Crack2
- Material Integrity Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Consequences Or Impact To Patient17
- No Information2
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Break
It was reported that an attune size 5 RP articulating surface was broken. There was no patient harm and no surgical delay reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843220 ↗MalfunctionApr 15, 2026Detachment of Device or Device Component
MISSING SPRING FROM ATTUNE ARTICULATING SURFACES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886316 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
INFORMED TODAY POST CASE THAT ONE SPRING WAS MISSING OFF THE ATTUNE ARTICULATING SIZE 5 TRIAL, THIS WAS REPORTED BY THE STERILE SERVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865609 ↗MalfunctionApr 6, 2026Break; No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE WAS BROKEN. IT IS UNKNOWN IF THE ITEM WAS DAMAGED BY THE CARRIER OR THE WAREHOUSE OR IF THE ITEM WAS IN THE MANUFACTURER'S BOX AND WAS DAMAGED WHEN IT WAS OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793244 ↗MalfunctionMar 20, 2026Break; Scratched Material
IT WAS REPORTED THAT THERE WAS A BROKEN AND SCRATCHED ATTUNE FEMORAL ARTICULATING TRIAL. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647762 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT THE ARTICULAR SURFACE TRIAL RING ATTACHMENT FOR SHIM BROKE OFF WHILE ASSEMBLING A TRIAL AT THE BEGINNING OF THE CASE. AS A RESULT, A PS TRIAL WAS USED INSTEAD, AND THE TRIAL WAS NOT REQUIRED. THERE WAS A SECOND DEVICE AVAILABLE ON THE TRAY AS AN ALTERNATIVE OPTION. THE EVENT DID NOT INVOLVE ANY PATIENT CONSEQUENCE OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512687 ↗MalfunctionDec 8, 2025Break; Break
IT WAS REPORTED THAT DEVICE BROKE DURING TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23750800 ↗MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE STERILE PROCESSING THAT THE SPRING ON THE SZ 5 RP CR TRIAL WAS MISSING AND LOT LOCKING ON THE SHIMS. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23646834 ↗MalfunctionNov 18, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, ONE OF THE SPRINGS CAME LOOSE AFTER REMOVING SHIM FROM THE ARTICURAR SERVICE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23587927 ↗MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, ONE OF THE SPRINGS CAME LOOSE AFTER REMOVING SHIM FROM THE ARTICURAR SERVICE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23587786 ↗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 23490028 ↗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 23486820 ↗MalfunctionSep 3, 2025Break; Break
IT WAS REPORTED A SIZE 5 ARTICULATING SURFACE SPRING BROKE DURING A PROCEDURE. THERE ARE 2 IN THE SET SO SURGEON WAS STILL ABLE TO TRAIL USING THE OTHER DEVICE. BROKEN PIECE WAS RETRIEVED. ALSO A TIBIAL MB IMPACTOR HAS CRACK, BUT WAS STILL ABLE TO BE USED. NO SURGICAL DELAY. NO PATIENT CONSEQUENCES. HIP AND KNEE, DATE J&J BECAME AWARE: 14/8/25, DATE OF EVENT: 13/8/25.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22952052 ↗MalfunctionJul 9, 2025Break; Break
IT WAS REPORTED THAT THE SZ 5 RP POLY TRIAL METAL SPRING BROKE WHERE THE SHIM ATTACHES. ALL PARTS WERE RETRIEVED BUT THE SPRING DID BREAK OFF WHILE ASSEMBLING ON THE BACK TABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22460968 ↗MalfunctionJul 9, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WERE BROKEN PIECES. THE DOG BONE AND ARTICULATING SURFACE ONES WERE MISSING THE LITTLE METAL RINGS THAT ALLOW THE SHIM ATTACHMENTS TO STAY ON. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22458835 ↗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 22288312 ↗MalfunctionApr 29, 2025Break; Break
IT WAS REPORTED THAT A SHIM HAS A CHIP IN IT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21928916 ↗MalfunctionDec 10, 2024Break; Break
IT WAS REPORTED ON NOVEMBER 26, 2024 MULTIPLE INSTRUMENTS ARE BROKEN/DAMAGED. DID NOT HAPPEN IN SURGERY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20895145 ↗MalfunctionAug 21, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT THE TRIAL INSTRUMENT HAS DEVELOPED A FAULT WITH THE SPRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20022533 ↗MalfunctionAug 13, 2024Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS REQUIRING REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19974962 ↗MalfunctionJun 27, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT NO ADVERSE EFFECTS WERE OCCURRING TO THE PATIENT. THE TIME OF THE DEFECT IS UNKNOWN. AND ANY ADVERSE CONSEQUENCES MAY HAVE BEEN A POSSIBLE ISSUE IN TRANSPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629549 ↗MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THIS INSTRUMENT IS COMPOSED OF 1 PART. THERE IS A SPRING MISSING. 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 problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18495534 ↗MalfunctionJan 11, 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, IP-01939499 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 18493277 ↗MalfunctionNov 29, 2023Material Integrity Problem; Material Integrity Problem
CSSD REPORTED THE INSTRUMENT WAS DAMAGED. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE ATTUNE RP CR ARTIC SURF SZ5 HAS ONE SPRING SEVERELY DEFORMED. ADDITIONALLY, ONE POST WAS FOUND CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18230821 ↗MalfunctionOct 30, 2023Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN POLY TRIAL FROM THE CONSIGNMENT TRAY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18035499 ↗
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- 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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