ATTUNE 2517-10-706Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION RP INSERT TRIAL SIZE 7 6MM · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295477051), received between Jun 1, 2018 and Jun 30, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (4 reports).
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
Most reported problems
Device problems
- Break4
- Appropriate Device Problem Term/Code Not Available1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Not Applicable2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2025Break; Break
IT WAS REPORTED THAT A PIECE BROKE OFF THE TRIAL AND THE OTHER HANDLES WERE BROKEN. IT DIDN'T HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22358044 ↗MalfunctionNov 27, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20795203 ↗MalfunctionNov 7, 2023Break; Break
IT WAS REPORTED THAT A PIECE OF THE TRIAL INSERT BROKE OFF. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18087633 ↗MalfunctionSep 12, 2018Break; Break
INSERT TRIAL BROKE WHILE REDUCING KNEE JOINT. ALL PIECES RECOVERED FROM THE PATIENT. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7870352 ↗MalfunctionJun 1, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT ATTUNE KNEE REVISION RP INSERT TRIAL SZ 7 6MM DID NOT FIT IN TRIAL FEMUR. MANUFACTURING ERROR. A REPLACEMENT TRIAL WAS ORDERED AND PUT OUR SET, AND WORKS WELL. MIGHT BE A PROBLEM WITH A SPECIFIC LOT. 2517-10-706 LOT AZ887033. SURGICAL DELAY FOR 5 MINUTES.
Patient problems: Not Applicable
MAUDE report 7562251 ↗MalfunctionJun 1, 2018Fitting Problem; Fitting Problem
IT WAS REPORTED THAT ATTUNE KNEE REVISION RP INSERT TRIAL SZ 7 6MM DID NOT FIT IN TRIAL FEMUR. MANUFACTURING ERROR. A REPLACEMENT TRIAL WAS ORDERED AND PUT OUR SET, AND WORKS WELL. MIGHT BE A PROBLEM WITH A SPECIFIC LOT.2517-10-706 LOT AZ898295. SURGICAL DELAY: 5 MINS.
Patient problems: Not Applicable
MAUDE report 7562224 ↗
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
- 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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