Arthrex® AR-9530S-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867062160), received between Sep 19, 2022 and Mar 18, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Defective Device

  ON 26-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-9530S-06 UNIVERS REVERS TRIAL IS DAMAGED. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629932 ↗
• MalfunctionJul 25, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9530S-06 ARTHREX® UNIVERS REVERS TRIAL HUMERAL INSERT 36 +6 INNER PLASTIC PART IS BROKEN. THE DEVICE WAS NOT USABLE DURING A CASE. THE DEVICE WAS SWAPPED OUT, AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610853 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-9530S-06 UNIVERS REVERS TRIAL WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005500 ↗
• MalfunctionFeb 18, 2025Break; Break

  ON 01/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4)THAT AN AR-9530S-06 HUMERAL POLY TRIAL IS BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398225 ↗
• MalfunctionFeb 13, 2025Break; Break

  ON (B)(6)2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9530S-06 ARTHREX® UNIVERS REVERS¿, TRIAL HUMERAL INSERT, WAS DAMAGED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED BY A SALES REPRESENTATIVE VIA PHONE, WHERE IT WAS REPORTED THAT THIS EVENT OCCURRED DURING A REVERSE TOTAL SHOULDER ON (B)(6) 2025 WHEN ONE OF THE PLASTIC PIECES FROM THE TRIAL INSERTS TWO HOLES THAT SNAP OUT, IT BROKE OFF. THE FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 21375925 ↗
• MalfunctionNov 7, 2024Break; Break

  ON 10/23/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-9530S-06 UNIVERS REVERS TRIAL HUMERAL INSERT HAS BEEN DAMAGED THROUGH WEAR AND TEAR. THIS WAS DISCOVERED DURING THE CASE, BUT DID NOT HAVE ANY ADVERSE EFFECTS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632099 ↗
• MalfunctionOct 30, 2024Break; Break

  ON 10/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530S-06 ARTHREX® UNIVERS REVERS¿, TRIAL HUMERAL INSERT 36 +6 BROKE DURING USE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORT OF PATIENT HARM.ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569408 ↗
• MalfunctionMar 7, 2024Dent in Material; Dent in Material

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530S-06 TRIAL HUMERAL INSERT WAS DENTED. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857289 ↗
• MalfunctionOct 31, 2023Naturally Worn; Naturally Worn

  ON 10/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530S-06 UNIVERS REVERS TRIAL 36 + 6 WAS DAMAGED FROM HEAVY USE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO ADVERSE EFFECTS FOR THE PATIENT. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/9/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2023. THE DEVICE LOOKED LIKE IT WAS GETTING CLOSE TO BREAKING, BUT IT DID NOT BREAK YET. NOTHING BROKE INSIDE THE PATIENT. THEY BRIEFLY USED THE COMPLAINT DEVICE BUT THEN WENT UP TO THE NEXT TRIAL SIZE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO CASE DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038433 ↗
• MalfunctionJun 19, 2023Break; Break

  ON 05/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9530S-06 TRIAL HUMERAL INSERT 36 +6 BROKE IN HALF. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2023. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17152516 ↗
• MalfunctionSep 19, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9530S-06 TRIAL HUMERAL INSERT 36 +6 BROKE. THIS OCCURRED DURING AN UNKNOWN CASE, WHILE BEING REMOVED THE DEVICE BROKE. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445942 ↗