Arthrex® AR-9150-19PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867057852), received between Dec 13, 2018 and Sep 2, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2020Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn

  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) 2017. DUE TO A COMPLETE TEAR OF THE RIGHT ROTATOR CUFF AND SUBSCAPULARIS INSUFFICIENCY 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: HUMERAL STEM: AR-9100-06S, GLENOID: AR-9106-02, HUMERAL HEAD: AR-9150-19P. TO COMPLETE THE REVISION SURGERY THE SURGEON USED AND ANTIBIOTIC WASH AFTER REMOVAL OF THE IMPLANTS AND 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 10483880 ↗
• InjuryJul 15, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A TSA CONVERSION TO AN RTSA, UPON TRYING TO REMOVE THE TSA UNIVERS APEX STEM, THE SLAP HAMMER NUBBIN BROKE OFF IN THE EXTRACTION TOOL LEAVING US WITH A BROKEN SLAP HAMMER. THIS RESULTED IN A DIFFICULT TIME TRYING TO REMOVE THE STEM ADDING AT LEAST 30 MINUTES TO THE CASE. NO ADDITIONAL INCISIONS WERE MADE. SURGEON USED SAME DELTOID/PECTORAL APPROACH FOR TOTAL SHOULDER ARTHROPLASTY PROCEDURE. THEY WERE UNABLE TO PERFORM A NORMAL REMOVAL TECHNIQUE SO THEY USED A TPS BURR TO HELP FACILITATE THE REMOVAL OF THE APEX STEM. NO ADDITIONAL ANESTHESIA WAS NEEDED. PRODUCT AR-9202-14, LOT 250150205, WILL BE RETURNED FOR EVALUATION. THE ORIGINAL TSA PROCEDURE TOOK PLACE (B)(6) 2020 DURING WHICH THE FOLLOWING DEVICES HAD BEEN IMPLANTED: AR-9106-02, UNIVERS VAULTLOCK GLENOID, LOT 1027261917. AR-9100-08S, UNIVERS APEX HUMERAL STEM, LOT 10321781. AR-9150-19P, USP II HUMERAL HEAD, LOT 10291252. THE ORIGINAL TSA AND RTSA WERE PREFORMED BY THE SAME SURGEON AT THE SAME FACILITY. CONVERSION PROCEDURE WAS BEING PERFORMED DUE TO A FAILED ROTATOR CUFF. ALL ORIGINAL IMPLANTS WERE EXPLANTED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10279254 ↗
• InjuryMay 14, 2020Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA THE SURGICAL OUTCOME SYSTEM THAT A PATIENT HAD PREVIOUS SHOULDER PROCEDURE. THE PATIENT EXPERIENCED LOOSENING OF THE IMPLANT ON THE HUMERAL SIDE THAT WAS UNRELATED TO ANY TRAUMA. THE PATIENT UNDERWENT A REVISION TO A DIFFERENT TYPE OF ARTHROPLASTY. PATIENT IS ONGOING AND IMPROVING. NO FURTHER INFORMATION WAS PROVIDED FROM THE SURGICAL OUTCOME SYSTEM. FURTHER INVESTIGATION IS IN PROCESS. ADDITIONAL INFORMATION OBTAINED 4/14/2020: PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY AND OPEN BICEPS TENOSIS PROCEDURE ON (B)(6) 2016. PATIENT BEGAN EXPERIENCING PAIN ISSUES IN (B)(6) 2018. ON (B)(6) 2020 THE SAME SURGEON PERFORMED A REVISION PROCEDURE AT THE SAME FACILITY. THE REVISION PROCEDURE WAS AN OPEN SURGERY, REVISION TO REVERSE REPLACEMENT. EXPLANTED PART NUMBERS ARE NOT YET KNOWN. PATIENT STUDY ID IS (B)(6). ADDITIONAL INFORMATION OBTAINED 04/22/2020: THE FOLLOWING ARE THE IMPLANT PART NUMBERS FROM THE ORIGINAL (B)(6) 2016 PROCEDURE. ALL OF THE DEVICES LISTED WERE EXPLANTED DURING THE REVISION PROCEDURE ON (B)(6) 2020. THE DEVICE DISPOSITION IS UNKNOWN: AR-9106-03 UNIVERS VAULTLOCK GLENOID (LOT 1027261550, AR-9150-19P UNIVERS II HUMERAL HEAD (LOT 150084918,

  Patient problems: Pain

  MAUDE report 10055592 ↗
• InjuryDec 13, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT REQUIRED A REVISION FROM AN APEX TOTAL SHOULDER THAT HE HAD IN (B)(6) 2017. THE REVISION WAS NEEDED DUE TO A TORN SUBSCAPULAR. THE ORIGINAL DEVICES WERE REMOVED AND REPLACED WITH AR-9560-24-2 AND AR-9561-30S. UPDATED 11/29/2018: PARTS/LOT PROVIDED BY THE SALES REP. ORIGINAL PROCEDURE SURGEON WAS DIFFERENT THAN THE REVISION SURGEON. BOTH PROCEDURES WERE PERFORMED AT THE SAME FACILITY. EXPLANTED DEVICES WERE AS FOLLOWS: AR-9100-06S, UNIVERS APEX HUMERAL STEM, LOT 10064881. AR-9106-02, UNIVERS VAULTLOCK GLENOID, LOT 1027261621. AR-7298, UNIVERS SPEX SUTURE KIT, LOT 10129987. AR-9150-19P, USP II HUMERAL HEAD, LOT 160084018.

  Patient problems: Excessive Tear Production

  MAUDE report 8160768 ↗