ATTUNE 2545-00-567Recalls & reported problems
Depuy (Ireland) · ATTUNE ARTICULATION SURFACE ROTATING PLATFORM CRUCIATE RETAINING SIZE 7 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE size 7 rotating platform knee trial component is a surgical instrument used to test implant fit during knee replacement. The 56 reports mostly describe trial parts breaking, cracking or chipping, springs coming loose or going missing, and pieces detaching — with no patient injuries and no deaths reported. One recall, started in June 2015 and closed, involved a small wire spring coil on the tibial trial instrument that could come apart 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
- 55
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295133070), received between Nov 21, 2017 and Sep 30, 2026 — classified as 55 malfunctions.
The most frequently reported specific device problem is “Break” (42 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
- Break42
- Detachment of Device or Device Component11
- Crack3
- Component Missing2
- Material Deformation2
- No Apparent Adverse Event2
- Material Integrity Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Consequences Or Impact To Patient12
- No Information1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947574 ↗MalfunctionAug 26, 2026Break
It was reported that Attune trials were broken and that pulled from pans buildup had generated multiple codes. Dates for each code breaking were not available. Notification was made in the morning. There were no adverse consequences that affected the patient due to the reported event. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50453835 ↗MalfunctionAug 26, 2026Break
It was reported that Attune trials were broken and that pulled from pans buildup had generated multiple codes. Dates for each code breaking were not available. Notification was made in the morning. There were no adverse consequences that affected the patient due to the reported event. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50453819 ↗MalfunctionMay 11, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT ONE POST ON THE ARTICULAR TRIAL WAS MISSING. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25143034 ↗MalfunctionApr 9, 2026Break
IT WAS REPORTED THAT THE PRODUCT DAMAGE 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 24831377 ↗MalfunctionJan 9, 2026Break
IT WAS REPORTED THAT THE SIZE 7 RP CR TRIAL WAS CHIPPED, AND THE SHIM WOULD NO LONGER SNAP ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24026333 ↗MalfunctionNov 7, 2025Break; Break
IT WAS REPORTED THAT THE SZ 7 RP ARTICULATION SURFACE SPRING WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23499011 ↗MalfunctionNov 7, 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 23496988 ↗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 23487051 ↗MalfunctionJul 24, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND WITHIN A BROKEN INSTRUMENTS TUB AT HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588420 ↗MalfunctionJun 19, 2025Break; Break
IT WAS REPORTED THAT THE SIZE 7 ATTUNE RP CR TRIAL WAS SNAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292846 ↗MalfunctionApr 29, 2025Break; Break
IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON (B)(6) 2025, AN ARTICULATING SURFACE WAS BROKEN. THE DEVICE WAS DISCARDED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925694 ↗MalfunctionMar 17, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL PIECE BROKE AFTER THE CASE, NO ADVERSE EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21626164 ↗MalfunctionFeb 18, 2025Break; Scratched Material; No Apparent Adverse Event; Break; Scratched Material; No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE ATTUNE ARTICULATING SURFACE 7RP IS BROKEN AND WORN. THE SPRING IS BROKEN AND THE SURFACE IS SCRATCHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405611 ↗MalfunctionNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, AN INSTRUMENT IS MISSING A SPRING. DAMAGE 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20747581 ↗MalfunctionNov 14, 2024Break; Break
IT WAS REPORTED ON NOVEMBER 5, 2024 THE LUG SNAPPED OFF DURING THE CASE SIZE 7 RP TIBIAL TRIAL. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20684240 ↗MalfunctionSep 4, 2024Break; Break
BROKEN ATTUNE RP CR ARTIC SURF TRIAL SZ7, GOUGE MARKS IN ATTUNE CR FEMORAL TRIAL SZ 5 LEFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20134770 ↗MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSTRUMENT WAS MISSING A SPRING. 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 19209311 ↗MalfunctionApr 9, 2024Crack; Crack
IT WAS REPORTED THAT INSTRUMENT IS CRACKED. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19070777 ↗MalfunctionMar 5, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
EACH INSTRUMENT IS COMPOSED OF 1 PART. THE SPRINGS OF EACH INSTRUMENT ARE TANGLED OR NON-UNIFORM. 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 18841285 ↗MalfunctionJan 26, 2024Break; Break
I WAS NOTIFIED BY CENTRAL SUPPLY THAT THE ATTUNE INSTRUMENT WAS BROKEN. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18590472 ↗MalfunctionOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSTRUMENT IS MISSING ONE OF THE CIRCULAR SPRINGS. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17939049 ↗MalfunctionOct 13, 2023Break; Break
IT WAS REPORTED THAT THE ARTIC SURF TAB ON BOTTOM BROKE OFF THE ART TOP. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17929617 ↗MalfunctionOct 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THAT THE TRIAL WAS MISSING A SPRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17887381 ↗MalfunctionAug 3, 2023Break; Break
IT WAS REPORTED THAT THE ATTUNE RP TRIAL BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17452443 ↗
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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