Arthrex® AR-9100-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867134522), received between Jan 30, 2019 and Jan 30, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryJan 30, 2019Difficult to Remove; Patient-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER "ARTHOPLASTY" PROCEDURE WHERE A 9MM HUMERAL STEM, AR-9100-09 WAS IMPLANTED. AFTER AN UNKNOWN AMOUNT OF TIME, THE PATIENT BEGAN HAVING PERSISTENT PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 AND THE STEM, AR-9100-09 WAS REMOVED. THERE WERE TWO ADDITIONAL IMPLANTS THAT WERE EXPLANTED, THE STEM AND THE HEAD; HOWEVER AT THIS TIME, THE PART NUMBERS ARE UNKNOWN. THE "TRUNION" FROM THE STEM WAS STUCK INSIDE THE HEAD AND UNABLE TO BE SEPARATED SO THE REP WAS NOT ABLE TO READ THE ITEM NUMBER ON THE HEAD COMPONENT. THE REVISION WAS COMPLETED WITH HARDWARE FROM ANOTHER MANUFACTURER.

  Patient problems: Pain

  MAUDE report 8290228 ↗