Arthrex® AR-9531Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867062184), received between Apr 11, 2022 and Jun 10, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Break; Break

  ON 01/31/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9531 HUMERAL LINER IMPACTOR BROKE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 01/30/2023: THE PROCEDURE PERFORMED WAS RSA ON (B)(6) 2023. THIS WAS DISCOVERED DURING THE IMPLANTATION OF HUMERAL CUP POLY WHICH IS THE LAST PART OF THE CASE. THE BONE QUALITY OF THE PATIENT WAS GOOD. NO FRAGMENTS BROKE INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498620 ↗
• MalfunctionJun 7, 2024Crack; Crack

  IT WAS REPORTED DURING A REVERSE TOTAL SHOULDER PROCEDURE, WHEN THE SURGEON HIT THE AR-9531, IMPACTOR WITH THE MALLET THE TIP CRACKED. THE SURGEON USED A SECOND AR-9533, IMPACTOR TO COMPLETE THE PROCEDURE. WHEN THE CASE WAS COMPLETED THE AR-9592-2420, WAS STICKING TOGETHER NOT COMING APART FOR STERILIZATION.

  Patient problems: Insufficient Information

  MAUDE report 19490854 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED ON 10/28/2022 BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9531 HUMERAL LINER IMPACTOR PLASTIC TIP BROKE OFF. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19471793 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED ON 10/03/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9531 HUMERAL LINER IMPACTOR CAP IS BROKEN OFF. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354299 ↗
• MalfunctionFeb 13, 2024Naturally Worn; Naturally Worn

  ON 01/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-9531 HUMERAL LINER IMPACTORS PLASTIC TIPS WORE OUT AND KEPT FALLING OFF THE HANDLE. THIS OCCURRED DURING A CASE, WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697159 ↗
• MalfunctionFeb 13, 2024Naturally Worn; Naturally Worn

  ON 01/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-9531 HUMERAL LINER IMPACTORS PLASTIC TIPS WORE OUT AND KEPT FALLING OFF THE HANDLE. THIS OCCURRED DURING A CASE, WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697106 ↗
• MalfunctionMay 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9531 HUMERAL LINER IMPACTOR HEAD FELL OFF. THIS OCCURRED DURING AN RTSA ON (B)(6) 2023 THE HEAD FELL OFF DUE TO THE THREADS BEING STRIPPED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON (04/18/2023, IT WAS REPORTED THAT ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED, AND THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906325 ↗
• MalfunctionApr 11, 2022Defective Component

  IT WAS REPORTED THAT DURING A SHOULDER PROSTHESIS SURGERY THE WHITE CAP OF THE DEVICE WAS DEFECT. THE THREAD COULDN`T BE SCREWED. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 28-MAR-2022: IT WAS CONFIRMED THAT THE WHITE CAP OF THE DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075386 ↗