NA 2178-65-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295096641), received between Nov 6, 2017 and Dec 1, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE. THE ATTUNE REV DISTAL AUG 8 MM FOR 3- 4 DOESN'T SLIDE IN AND OUT OF FEMUR PROPERLY, LOOKS BENT. WHILE THE 1.5 MBT REV CLEAR TRIAL BROKE IN HALF, NO PIECES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894580 ↗
• MalfunctionSep 10, 2021Break; Break

  (B)(4). IT WAS REPORTED THAT THE VIEW PLATE BROKE DURING NORMAL USE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453505 ↗
• MalfunctionMay 6, 2020Crack; Crack

  IT WAS REPORTED THAT THE DEFECTS WERE FOUND WHEN SETS RETURNED TO THE OFFICE FOR INSPECTION: SZ 1.5 MBT REV VIEW PLATE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10028705 ↗
• MalfunctionOct 3, 2019Break; Break

  THE DEFICIENCY IS THE PRODUCT IS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152154 ↗
• MalfunctionMay 23, 2019Material Deformation; Material Deformation

  SCUFFED PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637597 ↗
• MalfunctionSep 24, 2018Break; Break

  IT WAS REPORTED THAT VIEW PLATE CRACKED IN TWO PIECES. SURGERY TIME WAS NOT DELAYED AS WE USED A SIZE 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901797 ↗
• MalfunctionApr 4, 2018Break; Break

  DER STATES THAT THE TRAY TRIAL WAS NOT USED DURING SURGERY. DISCOVERED BROKEN ON CLEAN UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396442 ↗
• MalfunctionNov 6, 2017Break; Break

  IT WAS REPORTED THAT THE SZ 1.5 MBT PREP VIEW PLATE WAS FOUND BROKEN AFTER EXITING WASHER STERILIZER.

  Patient problems: No Information

  MAUDE report 7005295 ↗