Arthrex® AR-9152-20PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867057883), received between Dec 21, 2021 and May 1, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fitting 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2024Fitting Problem; Fitting Problem

  ON 12/1/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9100-09P HUMERAL STEM, AN AR-9152-20P HUMERAL HEAD, AND AN AR-9100-07S UNIVERS APEX HUMERAL STEM ALL FAILED TO FIT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. SURGEON COMPLETED CASE BY USING A LARGER STEM. ADDITIONAL INFORMATION RECEIVED 12/3/2021: THIS OCCURRED DURING A TOTAL SHOULDER ARTHROPLASTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219795 ↗
• InjuryDec 21, 2021Material Fragmentation; Output Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TSA PROCEDURE ON (B)(6) 2019 WHERE AN ARTHREX BALL AND SOCKET (PNS UNKNOWN, PENDING OPERATIVE REPORT) WERE IMPLANTED INTO THE PATIENT¿S RIGHT SHOULDER. DURING THE PATIENT¿S FOLLOW UP APPOINTMENT, THE PATIENT COMPLAINED OF PAIN IN HIS RIGHT SHOULDER AND AN X-RAY WAS TAKEN. ACCORDING TO THE SURGEON, THERE WAS NOTHING SHOWING ON THE X-RAY THAT WAS UNUSUAL. THE SURGEON SUGGESTED THE PAIN WAS DUE TO INTERNAL SUTURES IN THE PATIENT¿S BICEP BUT NO FURTHER MEDICAL TREATMENT WAS PERFORMED. THE PATIENT OPTED TO SEE A DIFFERENT SURGEON FOR THE PAIN AND IN (B)(6) 2021 (EXACT DATE UNKNOWN, PENDING OPERATIVE REPORT), A LAPAROSCOPIC PROCEDURE WAS PERFORMED FOR AN INTERNAL VISUAL. ONCE INSIDE THE JOINT, THE SURGEON FOUND THAT THE SOCKET HAD EXPLODED. HE BROKE DOWN THE FRAGMENTS AND REMOVED THE FRAGMENTS AND CEMENT FROM THE TSA PROCEDURE ARTHROSCOPICALLY¿NO DEVICES WERE IMPLANTED DURING THIS PROCEDURE. TO DATE, THE PATIENT IS STILL EXPERIENCING PAIN IN THE RIGHT SHOULDER AS IT IS NOW BALL ON BONE AND ALSO HAS A DECREASE IN ROM. THE PATIENT HAS SEEN A THIRD SURGEON WHO HAS SUGGESTED AN RTSA, HOWEVER, NO PROCEDURE HAS BEEN SCHEDULED. ADDITIONAL INFORMATION

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 13054443 ↗