Arthrex® AR-9509-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867061606), received between Jun 6, 2017 and Dec 6, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2022Entrapment of Device; Improper or Incorrect Procedure or Method; Entrapment of Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9509-S ARTHREX UNIVERS REVERS HUMERAL PROTECTOR WAS LEFT IN THE PATIENT DURING A TSA PROCEDURE. THIS WAS DISCOVERED DURING A POST-OPERATION VISIT, VIA X-RAY. REVISION SURGERY HAS BEEN SCHEDULED TO REMOVE THE PROTECTOR, BUT EXACT DATE IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 15923926 ↗
• InjuryJun 6, 2017Device Slipped

  IT WAS REPORTED VIA MEDWATCH (B)(4). THAT DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE A HUMERAL HEAD PROTECTOR, AR-9509-S, WAS UTILIZED TO ENSURE THE HUMERAL HEAD DID NOT FRACTURE. IT WAS REPORTED THAT THE HUMERAL HEAD PROTECTOR SLIPPED BEHIND THE SHOULDER INTO THE DELTOID MUSCLE, OUT OF SITE OF THE SURGEON. THE WOUND WAS CLOSED AND THE PATIENT WAS DISCHARGED. UPON SURGEON REVIEWING THE POST-OP X-RAY IT WAS DISCOVERED THAT THE HUMERAL HEAD PROTECTOR HAD BEEN RETAINED IN THE WOUND. THE PATIENT WAS SCHEDULED TO RETURN TO THE OR FOR DEVICE REMOVAL. THIS INFORMATION WAS REPORTED UNDER CC114972 (MEDWATCH 1220246-2017-00190). ADDITIONAL INFORMATION OBTAINED (B)(6) 2017: ORIGINAL PROCEDURE WAS (B)(6) 2017. REVISION PROCEDURE WAS (B)(6) 2017. DURING THE REVISION ONLY THE HUMERAL HEAD PROTECTOR, AR-9509-S, WAS EXPLANTED. PER CUSTOMER DEVICE WILL NOT BE RETURNED BUT IS AVAILABLE ON SITE FOR EVALUATION IF NEEDED.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 6615171 ↗
• InjuryJun 6, 2017Device Slipped

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE A HUMERAL HEAD PROTECTOR, AR-9509-S, WAS UTILIZED TO ENSURE THE HUMERAL HEAD DID NOT FRACTURE. IT WAS REPORTED THAT HUMERAL HEAD PROTECTOR SLIPPED BEHIND THE SHOULDER INTO THE DELTOID MUSCLE, OUT OF SITE OF THE SURGEON. THE WOUND WAS CLOSED AND THE PATIENT WAS DISCHARGED. UPON SURGEON REVIEWING THE POST-OP X-RAY IT WAS DISCOVERED THAT THE HUMERAL HEAD PROTECTOR HAD BEEN RETAINED IN THE WOUND. THE PATIENT WAS SCHEDULED TO RETURN TO THE OR FOR DEVICE REMOVAL ANOTHER TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 6615168 ↗