ATTUNE 2545-00-997Recalls & reported problems
Depuy (Ireland) · ATTUNE CONV RP PS ARTICULATION SURFACE SIZE 7 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295135746), received between May 14, 2018 and Oct 4, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (5 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.
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-2143-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break5
- Component Missing1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2022Break; Break
IT WAS REPORTED THAT PS RP SZ 7 ARTICULATION BROKE WHILE PUTTING IN TO TRIAL. ALL PARTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15536230 ↗MalfunctionDec 1, 2021Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIM WAS BROKEN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12912268 ↗MalfunctionJul 16, 2020Break; Break
BROKEN FB TIBIAL IMPACTOR AND RP TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10283837 ↗MalfunctionJun 3, 2020Break; Break
BROKEN ATTUNE SHIM REPORTED BY CSSD STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10116372 ↗MalfunctionJan 23, 2019Component Missing; Component Missing
IT WAS REPORTED THAT THE ARTICULATING SURFACE CAME OUT OF WASH WITH MISSING SPRING AND THE TIBIAL IMPACTOR CAME OUT WITH CRACK. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8270364 ↗MalfunctionMay 14, 2018Break; Break
IT WAS REPORTED THAT THE SIZE 7 RP ARTICULATING SURFACE WAS BROKEN. ALL PIECES WERE REMOVED. NO SURGICAL DELAY NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7511188 ↗
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
- 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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