Arthrex® AR-9100-06PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867057050), received between Nov 19, 2018 and Dec 26, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2019Break; Detachment of Device or Device Component

  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 (B)(6) 2019 REVISION PROCEDURE. THE ORIGINAL PART NUMBERS THAT WERE IMPLANTED DURING THE 2009 PROCEDURE ARE CURRENTLY UNKNOWN. THE (B)(6) 2019 PROCEDURE WAS REPORTED TO BE A STANDARD REVISION FOR A FAILED ROTATOR CUFF. IT WAS THAT THE PATIENT HAD NOT SUFFERED ANY INJURY OR TR

  Patient problems: No Code Available

  MAUDE report 9519381 ↗
• InjuryAug 14, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE TRUNNION OF THE AR-9100-06P UNIVERS II STEM (SIZE 6) WOULD NOT REMAIN ENGAGED WITH THE PROXIMAL STEM BODY TO FACILITATE STEM EXTRACTION DURING A TSA REVISION TO RSA PROCEDURE. AFTER SEVERAL ATTEMPTS TO RE-ENGAGE, THE TRUNNION WOULD STILL NOT ENGAGE. A SEPARATE STEM AR-9100-13P (LOT:16.00283) WAS OPENED AND THAT TRUNNION WAS USED TO SUCCESSFULLY EXTRACT THE STEM FROM THE PATIENT WITHOUT FURTHER PROBLEMS. THE COMPLAINT DEVICE WILL BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 07/29/2019: THE REP STATED THE REVISION PROCEDURE WAS DUE TO THE PATIENT FALLING AND TEARING THEIR SUBSCAPULARIS. THE SURGEON DETERMINED A REVISION WAS THE BEST PLAN OF ACTION. PRIOR TO THE REVISION PROCEDURE TAKING PLACE THE PATIENT WAS EXPERIENCING DISCOMFORT DUE TO CHRONICALLY DISLOCATING THEIR SHOULDER AS A RESULT OF THE TORN ROTATOR CUFF. THE REP STATED THE DATE OF THE FALL IS UNKNOWN. THE PRIMARY ANATOMIC TSA PROCEDURE TOOK PLACE IN (B)(6) 2018, AND WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE REVISION AND TOOK PLACE AT THE SAME FACILITY. THE BONE QUALITY WAS MEDIUM. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE, AND EXPLANTED DURI

  Patient problems: Discomfort; Fall; Joint Dislocation

  MAUDE report 8893507 ↗
• InjuryNov 19, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA (B)(6) STUDY PROGRAM THAT THE FOLLOWING ARTHREX PARTS WERE IMPLANTED ON (B)(6) 2014: HUMERAL STEM: AR-9100-06P ¿ LOT # 2501343611, HUMERAL HEAD: AR-9148-19P ¿ LOT # 2501245007, 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 "SUBACHROMIAL" 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. CT RES

  Patient problems: Discomfort; Hematoma; Pain; Swelling

  MAUDE report 8083813 ↗