Arthrex® AR-9148-21PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867057838), received between Oct 4, 2019 and Dec 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2019Break

  IT WAS REPORTED THAT WHILE EXTRACTING A TSA LONG STEM, AFTER USING THE FLEXIBLE OSTEOTOMES, THE SLAP HAMMER, AR-9202-14, WAS PUT ON TO THE STEM. AFTER NUMEROUS HITS, THE BALL BROKE OFF. THERE WERE NO FRAGMENTS IN THE PATIENT. THE REP OPENED A SECOND SET AND USED THE SLAP HAMMER FROM THAT TRAY TO COMPLETE THE CASE WITH NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION OBTAINED 10/31/2019: THE CASE WAS A REVISION PROCEDURE, MOVING TO A REVERSE TOTAL SHOULDER. THE PREVIOUS IMPLANT HAD BEEN IN FOR SEVERAL YEARS. FLEXIBLE OSTEOTOMES WERE USED EXTENSIVELY. IT WAS A LONG STEM AND A NUMBER OF TRIES, BACK AND FORTH FROM SLAP HAMMER TO OSTEOTOMES WAS PERFORMED WHEN THE BALL OF THE SLAP HAMMER POPPED OFF. ADDITIONAL INFORMATION OBTAINED 11/1/2019: THE ORIGINAL ARTHREX UNIVERS PROCEDURE TOOK PLACE IN 2009. SPECIFIC PROCEDURE DATE IS UNKNOWN. THE ORIGINAL 2009 PROCEDURE TOOK PLACE AT THE SAME FACILITY AS THE CURRENT OCTOBER 16, 2019 REVISION PROCEDURE. THE ORIGINAL PART NUMBERS THAT WERE IMPLANTED DURING THE 2009 PROCEDURE ARE CURRENTLY UNKNOWN. THE OCTOBER 2019 PROCEDURE WAS REPORTED TO BE A STANDARD REVISION FOR A FAILED ROTATOR CUFF. IT WAS THAT THE PATIENT HAD NOT SUFFERED ANY INJURY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9519370 ↗
• InjuryOct 4, 2019Positioning Problem

  IT WAS REPORTED BY THE PATIENT THAT HE HAD ARTHREX IMPLANTS IMPLANTED IN 2018. ACCORDING TO THE IMPLANT CARD, THE FOLLOWING DEVICES WERE IMPLANTED: AR-9100-09P & AR-9148-21P. THE PATIENT WAS CONTINUOUSLY EXPERIENCING VERY INTENSE (UNBEARABLE) PAIN. THE PATIENT WAS TREATED SEVERAL TIMES BY DIFFERENT DOCTORS DUE TO THE PAIN. THE RESULTS SHOWED THAT THE PROSTHESIS POSITION IS TOO HIGH AND HAS ONLY A SMALL JOINT GAP. DUE TO THE CONSTANT FRICTION, THE PATIENT NOW HAS A CHRONIC INFECTION. THE SECOND OPINION OF THE DOCTORS WAS THAT THE REMOVAL OF THE ENTIRE SHAFT (NOT CEMENTED) IS NECESSARY. HOWEVER, THIS LEADS TO THE FACT THAT THE ENTIRE HUMERUS MUST BE COMPLETELY DAMAGED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9155780 ↗