Arthrex® AR-9512Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867061866), received between Jul 6, 2023 and Nov 21, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Component Incompatible; Fitting Problem; Component Incompatible; Fitting Problem

  ON 11/03/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9512 UNIVERS REVERS¿ STEM/CUP EXTRACTION ADAPTER HANDLE WOULD NOT THREAD INTO THE SUTURE CUP TRIAL. IT WAS ATTEMPTED TO THREAD INTO OTHER SUTURE CUPS AND NONE WORKED. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE FROM A DIFFERENT HUMERAL 2 TRAY. WHEN COMPARED TO THE FUNCTIONAL INSERTER, IT WAS FOUND THAT THE COMPLAINT DEVICE HAD A SMALLER DIAMETER AT THE TIP AND THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618778 ↗
• MalfunctionNov 13, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-9512 REVERS' THREADS ON THE INSERTER ARE BROKEN. NOTICED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541671 ↗
• MalfunctionOct 31, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4). THAT AN AR-9512 EXTRACTOR HANDLE, THE BOLT THAT ATTACHES TO THE GIG THE BOLT AND JIG CROSS THREADED TOGETHER AND GOT STUCK, BROKE THE SCREWDRIVER BECAUSE IT WAS TIGHT. NOTICED DURING A CASE AND SWAPPED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439578 ↗
• MalfunctionJan 7, 2025Break; Break

  ON 12/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9511-2 UNIVERS REVERS IMPACTOR / EXTRACTOR ADAPTER BROKE OFF AND NO LONGER WORKS AS INTENDED, AND THE AR-9512 ARTHREX UNIVERS REVERS¿ STEM/CUP EXTRACTION ADAPTER HANDLE SHEARED OFF WHILE THREADED INTO THE AR-9511-2 UNIVERS REVERS IMPACTOR / EXTRACTOR ADAPTER. ALL PIECES THAT BROKE FROM BOTH DEVICES WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT AR-9511-2 UNIVERS REVERS IMPACTOR / EXTRACTOR ADAPTER. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093496 ↗
• MalfunctionNov 25, 2024Material Deformation; Material Deformation

  ON 10/30/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9512 ARTHREX UNIVERS REVERS STEM/CUP EXTRACTION ADAPTER HANDLE HAD AN ISSUE AFTER REMOVING THE TRIAL SUTURE CUP FROM THE JOINT DURING AN RTSA PROCEDURE ON (B)(6) 2024. THE SURGEON HAD DIFFICULTY EXTRACTING THE APEX STEM BROACH TRIAL FROM THE HUMERUS. IT APPEARED THE TRIAL BROACH KICKED WHEN IMPACTING THE TRIAL SUTURECUP. THE BROACH HANDLE WAS NOT ABLE TO EXTRACT THE TRIAL STEM. THE SURGEON WAS THEN RECOMMENDED TO USE THE AR-9512 THREADED ROD TO EXTRACT THE TRIAL STEM, BUT WAS UNSUCCESSFUL. THE TRIAL STEM WAS REMOVED AFTER ABOUT 15 MINUTES WITH A BONE HOOK. IT WAS UNCLEAR IF THE AR-9512 WAS DAMAGED IN THIS PARTICULAR PROCESS OF ATTEMPTED EXTRACTION, BUT INSPECTION AFTER THE CASE SHOWED THAT THE THREADS APPEARED FLATTENED/DAMAGED (PHOTO IS ATTACHED). NO PIECES BROKE INSIDE THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS NOTICED DURING USE, AND NO HARM WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771679 ↗
• MalfunctionOct 30, 2024Material Deformation; Material Deformation

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9512 STEM CUP EXTRACTOR THREADS ARE STRIPPED AND WILL NO LONGER ENGAGE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20565962 ↗
• MalfunctionJun 27, 2024Break; Break

  ON 5/30/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9512 ARTHREX UNIVERS REVERS STEM/CUP EXTRACTION ADAPTER HANDLE TIP BROKE OFF DURING USE. A PHOTO IS ATTACHED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/5/2024: THE AR-9512 ARTHREX UNIVERS REVERS STEM/CUP EXTRACTION ADAPTER HANDLE TIP BROKE OFF DURING EXTRACTION OF THE SUTURE CUP WHILE INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO CASE DELAY REPORTED. THIS WAS DISCOVERED DURING A REVISION REVERSE SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED BY OPENING ANOTHER TRAY WITH THE SAME DEVICE. NO ADVERSE EFFECTS ON THE PATIENT REPORTED DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622243 ↗
• MalfunctionDec 15, 2023Break; Break

  ON 11/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9512 ARTHREX UNIVERS REVERS STEM/CUP EXTRACTION ADAPTER HANDLE BROKE OFF INSIDE OF AN AR-9522-135R ARTHREX UNIVERS REVERS TRIAL CUP. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON 11/17/2023. THE CASE WAS COMPLETED BY USING THE INSTRUMENTS FROM ANOTHER TRAY. ADDITIONAL INFORMATION RECEIVED ON 11/21/2023: WHEN THE ADAPTER HANDLE BROKE OFF INSIDE THE TRIAL CUP, THE DEVICE WAS INSIDE THE PATIENT; HOWEVER, THERE WERE NO LOOSE FRAGMENTS IN THE PATIENT. THE CASE WAS DELAYED TWO MINUTES WHILE WAITING FOR ANOTHER TRAY TO BE OPENED USE THE INSTRUMENTS AND CONTINUE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18340874 ↗
• InjuryJul 6, 2023Break; Break

  ON 06/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9512 STEM/CUP EXTRACTION ADAPTER HANDLE WAS STRIPPED, AND AN AR-1999HH RATCHETING HANDLE BROKE. THIS OCCURRED DURING AN REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION CASE ON (B)(6) 2023, WHILE TAKING THE SUTURE-CUP OUT OF THE AR-9512 IT STRIPPED AND COULD NOT TWIST INTO THE SUTURE-CUP. WHILE TAKING THE BASEPLATE OUT THE AR-1999HH BROKE AND DID NOT RATCHET APPROPRIATELY. ANOTHER OF THE SAME PART WAS USED TO CONTINUE. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 06/26/2023, IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE IN WHICH AR-9502F-42RCPC SUTURE CUP, AN AR-9503L-03C HUMERAL INSERT, AND AN AR-9550-09 UNIVERS REVERS¿ SPACER WERE IMPLANTED. ON (B)(6) 2023 THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION PROCEDURE WHERE THE AR-9502F-39RCPC, AND AR-9503M-06 WERE EXPLANTED. THE CASE WAS COMPLETED USING OTHER PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17273165 ↗