ATTUNE 2517-00-406Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295476436), received between Jul 10, 2019 and Jul 10, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ONCE THE REVISION SURGERY WAS COMPLETED (IT¿S REPORTED AS PC-(B)(4)). IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO CHECK EXTENSION AND FLEXION OF THE PATIENT'S KNEE JOINT DURING THE REVISION SURGERY ON (B)(6) 2019 BY USING THE TIBIAL INSERT TRIAL (P/N: 251700406) WITH THE INSTRUMENTS WHICH WERE COMBINED WITH THE EVALUATION BULLET NO SPIKE (P/N: 254500127) AND THE KEEL PUNCH (P/N: 254500173), HOWEVER THE SHAPE OF THE TIBIAL INSERT TRIAL DID NOT FIT WITH THE INSTRUMENTS AND DID NOT ENGAGED. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775887 ↗