Arthrex® AR-9500-185Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867060616), received between Nov 21, 2017 and Nov 21, 2017 — classified as 1 injury.

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

• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING SEVERE PAIN AND SWELLING IN HER RIGHT FOOT AND ON (B)(6) 2017, AN ANATOEMIC PROSTHESIS SURGERY WAS PERFORMED AND AN AR-9500-185, ANATOEMIC PROSTHESIS 18.5MM WAS IMPLANTED (LOT 1410007). PATIENT STATED SHE HAD ALSO HAD A PRIOR BUNION SURGERY ON THAT SAME FOOT APPROXIMATELY 20 YEARS AGO. PATIENT STATES THAT HER RIGHT FOOT CONTINUES TO SWELL ON A DAILY BASIS AND IS CAUSING HER SIGNIFICANT PAIN. SHE IS UNABLE TO WEAR A NORMAL SHOE DUE TO THE SWELLING AND PAIN. PATIENT STATES SHE HAS NO KNOWN ALLERGIES TO METALS BUT DOES HAVE ALLERGIES TO MANY ANTIBIOTICS AND MANY MEDICATIONS MAKE HER VERY ILL. NO INFECTION OR ALLERGY TESTING HAS BEEN DONE AS OF TIME OF REPORT. PATIENT HAS SEEN HER SURGEON, WHO IN HER OPINION HAS BEEN DISMISSING HER SYMPTOMS AND HER. PATIENT WAS CALLING TO INQUIRE IF ARTHREX COULD DETERMINE IF THE DEVICE SIZE MIGHT HAVE BEEN WRONG FOR HER FOOT. PATIENT WAS INFORMED THAT ARTHREX IS NOT QUALIFIED TO MAKE THAT DETERMINATION AS ONLY A LICENSED MEDICAL PROFESSIONAL CAN DO SO. PATIENT WAS REFERRED BACK TO HER REGULAR SURGEON OR A DIFFERENT SURGEON FOR A SECOND OPINION. PATIENT WAS ALSO PROVIDED WITH THE MATERIAL COMPOSITION OF THE D

  Patient problems: Pain; Swelling

  MAUDE report 7048078 ↗