Arthrex® AR-9501-10CPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867061057), received between Nov 1, 2016 and Oct 20, 2023 — classified as 3 injuries.

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

• InjuryOct 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INITIAL SURGERY ON (B)(6) 2023 THE PATIENT DEVELOPED A SEVERE INFECTION WHICH AFFECTED THE PATIENT FOR 6 MONTHS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE INVOLVED IMPLANTS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 17976969 ↗
• InjuryDec 12, 2018Connection Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A UNIVERS REVERS SURGERY THE CUP CANNOT BE ATTACHED TO THE SHAFT. DUE TO THIS ISSUE THE SURGEON HAD TO CHANGE THE SURGICAL TECHNIQUE AND USED AR-9501-09CPC BECAUSE THERE WAS NO SECOND AR-9501-10CPC INSIDE THE LOANER SET. THE AR-9501-09CPC WAS CEMENTED IN. UPDATE 29 NOV 2018: THE SALES REP CONFIRMED THAT INITIALLY IT WAS PLANNED TO USE A 10MM SHAFT FOR THE UNIVERS REVERS SURGERY, BUT IT SHOULD NOT BE CEMENTED. THE CHANNEL FOR THE 10MM SHAFT WAS ALREADY PREPARED, THEN IT WAS NOTICED THAT THE CUP CANNOT BE CONNECTED TO THE 10MM SHAFT. BECAUSE THERE WAS NO SECOND 10MM SHAFT IN THE SET, AN 11MM SHAFT WAS TRIED, BUT AS IT WAS TOO BIG, THE 9MM SHAFT WAS USED. BUT IT WAS TOO SMALL FOR THE 10MM CHANNEL, THE 9MM HAD TO BE CEMENTED IN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155392 ↗
• InjuryNov 1, 2016Material Twisted/Bent

  IT WAS REPORTED THAT A MALE PATIENT HAD UNDERGONE A RIGHT REVERSE TOTAL SHOULDER PROCEDURE APPROXIMATELY TWO YEARS PRIOR IN ANOTHER STATE. ON (B)(6) 2016 PATIENT WAS UNDERGOING A PROCEDURE TO REMOVE THE PRIOR IMPLANTS DUE TO INFECTION. DURING THE PROCEDURE SURGEON WAS USING THE AR-8943-10, T15 HEXALOBE SCREWDRIVER ((B)(4) (B)(6)) AND THE THREADS TWISTED MAKING IT NO LONGER USABLE. THEN THE SURGEON USED THE AR-9202-T15H, UNIVERSAL GLENOID T15 LONG DRIVER ((B)(4) (B)(6)) AND FOUND THE THREADS TWISTED RENDERING IT UNUSABLE. THESE DEVICES ARE FROM LOANER SET RAR-9501GS #14. NO PATIENT INJURY REPORTED. THE CASE WAS COMPLETED USING HOSPITAL OWNED SPARE SCREWDRIVERS WHICH WERE ALSO IN BAD CONDITION. INFORMATION OBTAINED 10/13/16: PRIOR TO THE REVISION PROCEDURE PATIENT HAD A NORMAL BLOODWORK IN 2014, ASPIRATION OF 45CC IN (B)(6) 2016 AND POSITIVE TEST FOR PROPIONBACTERIUM ACNES. AT THE TIME OF THE REVISION AN EXTENDED HOLD CULTURE WAS DONE AND READ ON (B)(6) 2016 AS WELL AS (B)(6) 2016 AND IS CURRENTLY ONGOING. NO AEROBES ISOLATED OR ANEROBIC GROWTH OF BACTERIA FOUND. NO EVIDENCE OF MALIGNANCY. THE FOLLOWING PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-9504L-04 ((B)(4) (B)(6)),

  Patient problems: Unspecified Infection

  MAUDE report 6068946 ↗