Arthrex® AR-9104-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867057296), received between Nov 19, 2018 and Jan 26, 2021 — 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 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.

• InjuryJan 26, 2021Break

  IT WAS REPORTED VIA THE ARTHREX ETHICS HELPLINE THAT THE FOLLOWING ISSUE HAS OCCURRED: PATIENT HAD LEFT SHOULDER REPLACEMENT SURGERY APPROXIMATELY 9 YEARS AGO. X-RAYS HAVE BEEN TAKEN ON (B)(6) 2020 AND PATIENT WAS REFERRED BACK TO HIS ORIGINAL SURGEON. IT HAS BEEN DISCOVERED THAT A PIECE OF THE ARTHREX PROSTHESIS HAS BROKEN OFF AND IS MOVING ABOUT IN THE SHOULDER GIRDLE AREA, UNDER THE SKIN. THE SURGEON HAS PLANS TO PERFORM A SECOND SURGERY (B)(6) 2020, IT WAS INDICATED IN THE INITIAL REPORT THAT THE ISSUE COULD POSSIBLY BE DUE TO A FALL AND THAT THE ISSUE MAY HAVE OCCURRED APPROXIMATELY (B)(6) 2020. PATIENT STATED THAT HE IS CURRENTLY EXPERIENCING NO PAIN AND HIS JOINT IS FUNCTIONING AS IT ALWAYS HAS. ADDITIONAL INFORMATION OBTAINED 1/4/2020: THE PATIENT'S ORIGINAL SURGERY TOOK PLACE (B)(6) 2012. THE FOLLOWING ARE THE ARTHREX PRODUCTS THAT WERE IMPLANTED DURING THE ORIGINAL SURGERY: AR-9104-02 GLENOID, POLY WITH KEEL, MEDIUM. AR-9150-19P USP II HUMERAL HEAD 50/19. AR-9100-10P UNIVERS II HUMERAL STEM. PATIENT'S RELATIVE REPORTS THAT THE PATIENT EXPERIENCED, IN HIS LEFT SHOULDER, A DISPROPORTIONATE AMOUNT OF PAIN AND MOTION RESTRICTIONS THAT OCCURRED MID MAY 2020. HE HAD ASSISTED A

  Patient problems: Failure of Implant; Foreign Body In Patient; Pain; Tissue Damage

  MAUDE report 11228581 ↗
• InjuryNov 19, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA ECLIPSE STUDY PROGRAM THAT THE FOLLOWING ARTHREX PARTS WERE IMPLANTED ON (B)(6) 2014: 1. HUMERAL STEM: AR-9100-06P ¿ LOT # 2501343611; 2. HUMERAL HEAD: AR-9148-19P ¿ LOT # 2501245007; 3. KEELED GLENOID: AR-9104-02 ¿ LOT # 2501416710. IT WAS REPORTED THAT AFTER IMPLANTATION, THE PATIENT (SUBJECT (B)(6)) COMPLAINED OF INCREASED LEFT SHOULDER PAIN WHEN SLEEPING ON LEFT SIDE. PATIENT WAS GIVEN AN ULTRASOUND GUIDED ACROMIOCLAVICULAR JOIN INJECTION ON (B)(6) 2015. PATIENT WAS GIVEN A SECOND INJECTION ON (B)(6) 2015. ON (B)(6) 2016 PATIENT NOTED SLIGHTLY INCREASED PAIN WHILE PUSHING FATHER IN WHEELCHAIR. ON (B)(6) 2016 PATIENT UNDERWENT OPEN DISTAL CLAVICLE RESECTION. ON (B)(6) 2016 PATIENT WAS LIFTING THEIR FATHER OFF THE GROUND AFTER THE FATHER HAD FALLEN. THE PATIENT WAS EXPERIENCING INCREASED PAIN OVER ANTEROSUPERIOR LEFT SHOULDER AT THE INCISION SITE AND AC JOINT. IT WAS DISCOVERED THAT THE PATIENT HAD DEVELOPED A HEMATOMA. ON (B)(6) 2016 PATIENT CALLED WITH INCREASED PAIN. PATIENT HAD A SUBACROMIAL CORTISONE INJECTION TO THE LEFT SHOULDER. SUSPECTED ROTATOR CUFF PATHOLOGY. PATIENT COMPLETED THE STUDY ON (B)(6) 2016, BUT WAS STILL EXPERIENCING PAIN AND DISCOMFORT.

  Patient problems: Discomfort; Hematoma; Pain; Swelling

  MAUDE report 8083825 ↗