Arthrex® AR-9144-19PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867057708), received between Jan 2, 2019 and Jul 3, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionJul 3, 2025Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  ON 06/09/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9144-19P ARTHREX UNIVERS II 3D HUMERAL HEAD TRIAL SIZE LOST STABILITY AFTER THE IMPLANT WAS OPENED. THEY SWITCHED TO A LARGER IMPLANT SIZE, WHICH RESTORED THE REQUIRED STABILITY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 06/25/2025: THIS OCCURRED DURING AN ANATOMIC TOTAL SHOULDER PROCEDURE ON (B)(6) 2025. THE AR-9146-20P ARTHREX UNIVERS II 3D HUMERAL HEAD, 46/20 WAS USED TO COMPLETE THE CASE. NO CASE DELAY OR ADDED ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED DURING OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22397319 ↗
• InjurySep 2, 2020Device Dislodged or Dislocated

  IT WAS INITIALLY REPORTED VIA THE SURGICAL OUTCOME ALERT SYSTEM THAT A POSSIBLE REVISION MAY HAVE TAKEN PLACE WITH STUDY PATIENT (B)(6). FURTHER INVESTIGATION HAS NOW CONFIRMED THE FOLLOWING INFORMATION: THE STUDY PATIENT HAD A TOTAL SHOULDER ARTHROPLASTY (B)(6) 2018. DUE TO A ROTATOR CUFF/SUBLUXATION, DEFICIENT SUPRASPINATUS AND SUBSCAPULARIS THE PATIENT UNDERWENT A REVISION SURGERY (B)(6) 2018 AT THE SAME FACILITY BY THE SAME SURGEON. DURING THE REVISION SURGERY THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: GLENOID: AR-9106-02. HUMERAL STEM: AR-9100-09S. HUMERAL HEAD: AR-9144-19P. TO COMPLETE THE REVISION SURGERY THE SURGEON USED AND ANTIBIOTIC WASH AFTER REMOVAL OF THE IMPLANTS A BONE ALLOGRAFT WAS USED ON THE GLENOID. HUMERAL CANAL WAS REAMED AND BROACHED IN 30 DEGREES OF RETROVERSION.

  Patient problems: No Code Available

  MAUDE report 10483811 ↗
• InjuryJul 15, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED, VIA THE SURGICAL OUTCOME SYSTEM, THAT A ARTHREX SHOULDER ARTHROPLASTY STUDY PATIENT ((B)(6)) WAS EXPERIENCING SUBSCAPULARIS FAILURE. UPON FURTHER INVESTIGATION THE FOLLOWING INFORMATION HAS BEEN OBTAINED: THE PATIENT HAD A PRIMARY PROCEDURE ON (B)(6) 2016. DURING THAT PROCEDURE THE FOLLOWING DEVICES HAD BEEN INSTALLED: AR-9100-08S HUMERAL STEM, AR-9144-19P HUMERAL HEAD AND AR-9105-02 GLENOID. THE PATIENT BECAME SYMPTOMATIC IN EARLY (B)(6) 2020 FOR SUBSCAPULAR AND SUPRASPINATUS RUPTURE. CT SCAN FINDINGS CONFIRMED ROTATOR CUFF TEAR ON (B)(6) 2020. A REVISION REVERSE SHOULDER ARTHROPLASTY WILL BE SCHEDULED UPON RESOLUTION OF THE CURRENT COVID-19 PANDEMIC. ADDITIONAL INFORMATION PROVIDED 6/2/2020: REVISION SURGERY IS SCHEDULED TO TAKE PLACE (B)(6) 2020. ADDITIONAL INFORMATION PROVIDED 6/26/2020: IT HAS BEEN CONFIRMED THAT THE REVISION SURGERY TOOK PLACE ON (B)(6) 2020 AT THE SAME FACILITY AND BY THE SAME SURGEON AS THE ORIGINAL PROCEDURE. THE ORIGINAL IMPLANTS WERE EXPLANTED AND THE FOLLOWING DEVICES WERE IMPLANTED DURING THE REVISION: BASEPLATE: AR-9560-24-2 155527. CENTRAL SCREW: AR-9561-30S 155541. GLENOSPHERE: AR-9564-2436-LAT 155566. HUMERAL STEM: AR-9501-09P 1456

  Patient problems: Excessive Tear Production

  MAUDE report 10279551 ↗
• InjuryJan 2, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2017 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-9100-10S LOT: 10055062; AR-9106-01 LOT: 1027261611 AND AR-9146-20P LOT: 160051618. ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION TSA/GLENOID REVISION AND HUMERAL HEAD SIZE REDUCTION (CAPTURED ON CASE (B)(4)) FOR AN UNKNOWN REASON AND THE FOLLOWING DEVICES WERE EXPLANTED: AR-9106-01 LOT: 1027261611 (MEDWATCH 1220246-2019-00828) AND AR-9146-20P LOT: 160051618 (MEDWATCH 1220246-2019-00829) AND REPLACED WITH: AR-9105-01 LOT: 113601629 AND AR-9144-19P LOT: 160047318. THE PATIENT THEN UNDERWENT A SECOND REVISION TSA ON (B)(6) 2018. UPON ENTERING THE JOINT SPACE, THE SURGEON REALIZED THE HEAD WAS BARELY ASSOCIATED TO THE TRUNION. MOREOVER, THE TRUNION WAS DISASSOCIATED FROM THE STEM AS WELL AND THE SUPERIOR VERSION SCREW WAS BACKED ALL THE WAY OUT. ESSENTIALLY THE STEM FELL APART INTO 4 PIECES: THE SCREW, THE HEAD, THE STEM, AND THE TRUNION. THE FOLLOWING DEVICES WERE EXPLANTED AND REPLACED WITH A SYSTEM FROM ANOTHER MANUFACTURER: AR-9100-10S LOT: 10055062 (IMPLANTED DURING (B)(6) 2017 ORIGINAL PROCEDURE); AR-9105-01 LOT: 113601629 (IMPLANTED DURING

  Patient problems: No Code Available

  MAUDE report 8209559 ↗