Arthrex® AR-9510-06RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867061675), received between May 15, 2024 and Jun 12, 2024 — classified as 2 malfunctions.

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

• MalfunctionJun 12, 2024Corroded; Corroded

  ON 05/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-12R, AR-9510-09R, AND AR-9510-06R RASP IS RUSTY AND DISCOLORED. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521251 ↗
• MalfunctionMay 15, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A UNIVERS REVISION REVERS CTA PROCEDURE COMPLICATIONS OCCURRED. DUE TO THE FACT THAT THE TRIAL IMPLANT IS SMALLER THAN THE REGULAR IMPLANT AR-9501-06RCPC PROBLEMS OCCURRED. AS THE SURGEON HAS NOT REMOVED ALL THE CEMENT IN THE LOWER PART OF THE HUMERUS THE TRAIL IMPLANT FIT IN BUT THE REGULAR IMPLANT DID NOT. DUE TO THIS FAILURE THE PROCEDURE BECAME MORE COMPLICATED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 03-AUG-2022 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT A SPACER FROM AN UNKNOWN MANUFACTURER WAS PLACED INSIDE THE PATIENT AS SHE HAD MULTIPLE SURGERIES PRIOR TO THE REPORTED REVISION. IT IS UNKNOWN WHAT PROSTHESIS WAS IMPLANTED PRIOR TO THE MULTIPLE SURGERIES. NO FURTHER INFORMATION ARE AVAIALBLE WHAT DEVICE WAS INITIALLY IMPLANTED AND WHEN THE INITIAL SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319089 ↗