Arthrex® AR-9148-19PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867057821), received between Nov 19, 2018 and Jun 6, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2022Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2020. IN (B)(6) OF 2021, PATIENT COMPLAINED OF PAIN. ON (B)(6) 2022, PATIENT WAS POSITIVE FOR A C. ACNES INFECTION AND UNDERWENT REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION ARTHROPLASTY SURGERY, AN AR-9106-02 ARTHREX UNIVERS VAULTLOCK GLENOID, AN AR-9100-10S UNIVERS APEX HUMERAL STEM, AND AN AR-9148-19P ARTHREX UNIVERS II 3D HUMERAL HEAD WERE EXPLANTED. CASE WAS COMPLETED BY IMPLANTING AN ANTIBIOTIC CEMENT SPACER. THE ORIGINAL SHOULDER ARTHROPLASTY PROCEDURE, WAS PERFORMED AT FOX VALLEY ORTHOPEDIC ASSOCIATES SURGERY CENTER BY A DIFFERENT SURGEON. ADDITIONAL INFORMATION RECEIVED ON 5/18/2022: ALL DEVICES THAT WERE IMPLANTED ON (B)(6) 2020 WERE EXPLANTED DURING REVISION SURGERY ON (B)(6) 2022. AFTER PATIENT COMPLAINT OF PAIN IN (B)(6) OF 2021, PATIENT WAS MONITORED AND REVISION SURGERY WAS SCHEDULE. DUE TO OTHER NON-ORTHOPEDIC REASONS, REVISION SURGERY WAS DELAYED UNTIL (B)(6) 2022. OTHER THAN THE ANTIBIOTIC CEMENT SPACER, NO NEW ARTHREX DEVICES WERE IMPLANTED DURING REVISION SURGERY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14602016 ↗
• InjuryMay 28, 2020Break; Loose or Intermittent Connection; Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT ON (B)(6) 2014 A TOTAL SHOULDER PROSTHESIS FROM ARTHREX THE UNIVERSAL-GLENOID WAS IMPLANTED INTO THE PATIENT. DURING THE YEAR 2018 IT WAS SHOWN ON X-RAY PICTURES THAT THE PLASTIC INLAY OF THE IMPLANT WAS WORN OUT. THEREFORE A REVISION SURGERY WAS PERFORMED WHICH CONFIRMED THAT THE PLASTIC INLAY WAS EXFOLIATED, THINNED AND BROKEN. NO FURTHER INFORMATION WERE PROVIDED. UPDATE 18-MAY-2020: FURTHER INFORMATION WERE PROVIDED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. THE INITIAL RESULTS STATED THAT THE PATIENT HAD THE FEELING THAT THE SHOULDER IS JUMPING AND MAKING NOISE. WHICH WAS CONFIRMED DURING THE CLINICAL EVALUATION. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO A LOOSENING SHAFT AND INLAY DEGRADATION ON THE RIGHT SHOULDER. THE PROSTHESIS WAS REPLACED WITH AN INVERSE PROSTHESIS AND THE SHAFT WAS ALSO EXCHANGED.

  Patient problems: No Code Available

  MAUDE report 10096431 ↗
• InjuryDec 12, 2018Break; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RIGHT REVISION TSA TO RTSA PROCEDURE, AFTER THE SURGEON INSERTED THE 33 GLENOSPHERE WITH THE GLENOSPHERE INSERTER, AR-9624, THE SURGEON WAS REMOVING THE INSERTER AND AS IT WAS UNSCREWED, HE NOTICED THAT THE TIP HAD BROKEN OFF. THE TIP OF THE INSERTER WAS LODGED IN THE GLENOSPHERE. THE SURGEON DECIDED TO LEAVE THE SHEARED OFF TIP IN THE GLENOSPHERE AS IT WAS TIGHT IN THE BASEPLATE AND WAS NOT SITTING PROUD. ADDITIONAL INFORMATION PROVIDED 11/19/2018: THE ORIGINAL APEX STEM WAS IMPLANTED DURING A TSA PROCEDURE ON (B)(6) 2016. SINCE THEN, THE STEM HAD DRIFTED TOWARDS THE LATERAL CORTEX, AS WELL AS A ROTATOR CUFF TEAR. ALL HARDWARE WAS EXPLANTED. IT WAS AN APEX STEM, A 48/19 HEAD, AND A PEGGED GLENOID COMPONENT. ADDITIONAL INFORMATION PROVIDED 11/21/2018: THE FOLLOWING THREE DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: AR-9100-06S; AR-9148-19P; AR-9105-02.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155339 ↗
• 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 8083820 ↗