Arthrex® AR-9510-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867061668), received between Sep 13, 2018 and Sep 13, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 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.

• InjurySep 13, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER, THE SURGEON SIZED THE HUMERAL STEM AND DECIDED TO USE THE AR-9501-06P THE ARTHREX UNIVERS REVERS HUMERAL STEM SIZE 6. THE OUTER PACKAGE WAS OPENED AND PLACED IN THE STERILE FIELD. THE SURGEON WAS REAMING TO PREP FOR THE CUP TO GO WITH THE STEM, AND AFTER REAMING HE ATTEMPTED TO DO A TRIAL AND REDUCE THE SHOULDER. THE SURGEON FELT THAT HE NEEDED THE TRIAL TO GO DEEPER. THE SURGEON USED A BROACH TO OBTAIN MORE DEPTH, AND WHILE GOING DEEPER WITH THE BROACH THE HUMERUS FRACTURED. AFTER THE HUMERUS FRACTURED, THE SURGEON SIZED UP ON THE BROACH TO GET A BETTER FIT. AN AR-9501-07P, ARTHREX UNIVERS REVERS HUMERAL STEM, SIZE 7 WAS BROUGHT IN TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE REP STATED THAT THE BONE QUALITY OF THE PATIENT WAS SOFT AND FRAGILE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE BROACH. ADDITIONAL INFORMATION RECEIVED ON 09/07/2018: THE REP PROVIDED THE PART AND LOT NUMBER (AR-9510-06 / LOT: 250130401) OF THE BROACH THAT WAS USED DURING THE PROCEDURE THAT CAUSED THE HUMERUS FRACTURE.

  Patient problems: Bone Fracture(s); Patient Problem/Medical Problem

  MAUDE report 7873300 ↗