ATTUNE 2511-01-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295437949), received between Dec 11, 2018 and May 13, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING DEMO WITH SURGEON, IT WAS DISCOVERED THAT 30 MM BROACH WAS NOT SECURING TO THE IMPLANT AS IT SUPPOSED TO. (WOULD NOT CONNECT DURING THE CASE EITHER - DID DEMO TO REVIEW). THE INNER THREADS ARE STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012089 ↗
• MalfunctionOct 6, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT IT WAS CHEWED UP. DIDN'T FEEL SAFE PUTTING IT BACK IN PAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551131 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISTAL FEMUR FX. OCCURRED EITHER DURING BROACHING FOR SLEEVE OR AT TIME OF IMPLANTATION OF PROSTHESIS.

  Patient problems: Limb Fracture

  MAUDE report 11517631 ↗
• MalfunctionJul 10, 2019Break; Break

  STERILE SERVICES REPORTED THAT A SMALL PIECE OF METAL BROKE OFF THE SIZE 30MM FEMORAL SLEEVE BROACH. IF OTHER, DESCRIBE --> THIS KIT WAS NOT USED ON A PATIENT AS IT WAS THERE AS A BACKUP, IF OTHER, DESCRIBE --> NOT USED ON A PATIENT, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775401 ↗
• MalfunctionDec 11, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING CADAVER TRAINING LAB THE JUMP FROM THE TIBIAL CONICAL REAMER TO THE 29MM TIBIAL BROACH WAS TOO LARGE AND THE GAPS BETWEEN THE TEETH ON THE TIBIAL BROACHES ARE TOO SMALL IN COMPARISON TO THE PREDICATE BROACHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8151638 ↗