Arthrex® AR-9100-08SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867134508), received between Mar 7, 2017 and Jun 14, 2024 — classified as 6 injuries, 1 malfunction.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED DURING A TOTAL SHOULDER ARTHROPLASTY - APEX/VAULTLOCK PROCEDURE THE INFERIOR, INCLINATION SCREW WOULD NOT ENGAGE WITH THE AR-9100-08S STEM. THE SURGEON TRIED FOR A WHILE WITH BOTH THE T-HANDLE DRIVER AND STANDARD DRIVER TO GET THIS SCREW TO ENGAGE. THE SURGEON REMOVED THE STEM AND REPLACED IT WITH ANOTHER 8MM APEX STEM AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19535791 ↗
• InjuryDec 7, 2021Loosening of Implant Not Related to Bone-Ingrowth

  ON 11/19/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9100-08S HUMERAL STEM AND AR-9154-21P HUMERAL HEAD WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. THE GLENOID ASPECT OF THE SURGERY SEEMED FINE BOTH DURING PRE-OP ASSESSMENT AS WELL AS INTRA-OP. ABOUT A YEAR AND A HALF AFTER IMPLANTATION, PATIENT BEGAN TO EXPERIENCE PAIN AND DISCOMFORT, IT LOOKED AS IF THE STEM HAD SUBSIDED AND IT WAS LOOSE. DURING THE REVISION SURGERY ON (B)(6)2021, SAMPLES WERE TAKEN FROM BOTH THE JOINT SPACE AND CANAL AREA. ALL TESTS CAME BACK NEGATIVE FOR INFECTION, WHICH LEADS TO THE ISSUE BEING ASEPTIC LOOSENING. ONCE THE STEM WAS REMOVED THERE WAS NO BONY ON OR INGROWTH IN THE IMPLANT. SURGEON WAS ABLE TO REPLACE BOTH HUMERAL STEM AND HUMERAL HEAD WITH AN AR-9501-10P REVERS HUMERAL STEM, AN AR-9501-FX10N REVERS FRACTURE ADAPTER, AND AN AR-9150-19P UNIVERS HUMERAL HEAD.

  Patient problems: Discomfort; Joint Laxity; Pain

  MAUDE report 12954076 ↗
• 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 6/2/20: REVISION SURGERY IS SCHEDULED TO TAKE PLACE (B)(6) 2020. ADDITIONAL INFORMATION PROVIDED 6/26/20: 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 145616. SU

  Patient problems: Rupture

  MAUDE report 10279483 ↗
• InjuryJul 15, 2020Break

  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: Failure of Implant

  MAUDE report 10279202 ↗
• InjuryNov 21, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT THE PATIENT HAD COMPLICATIONS RELATED TO MOTION LOSS. ADDITIONAL INFORMATION WAS OBTAINED THAT THE PATIENT HAD AN ARTHREX APEX UNIVERS TOTAL SHOULDER SYSTEM IMPLANTED DURING A (B)(6) 2018 PROCEDURE. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE (B)(6) 2018 PROCEDURE: UNIVERS APEX HUMERAL STEM AR-9100-08S (LOT 10070616), UNIVERS II HUMERAL HEAD AR-9146-18P (LOT 10129357), UNIVERS VAULTLOCK GLENOID MEDIUM AR-9106-02 (LOT 1027261721) AND FIBERTAPE TENDON COMPRESSION BRIDGE KIT WITH JUMPSTART DRESSING AR-7297 (LOT 10197428). DURING PATIENT'S (B)(6) 2019 FOLLOW UP WITH SURGEON IT WAS NOTED THAT THE PATIENT HAD A LACK OF HEALING OF HER SUBSCAPULARIS AND HAS BEEN SCHEDULED FOR REVISION SURGERY ON (B)(6) 2019. SURGEON HAS STATED THAT THE PATIENT HAD AN ANATOMIC ARTHROPLASTY WITH FAILURE OF SUBSCAPULARIS HEALING. WHICH WAS NOT ARTHREX DEVICE RELATED. A FOLLOW UP WILL BE DONE AFTER THE REVISION TAKES PLACES TO CONFIRM IF ANY ARTHREX PRODUCTS ARE EXPLANTED. ADDITIONAL INFO OBTAINED 10/2/19: THE FOLLOWING PARTS WERE IMPLANTED DURING THE (B)(6) 2019 PROCEDURE: AR-9106-02, UNIVERS VAULTLOCK GLENOID MEDIUM, LOT 1027261721, AR-9100-08S, UN

  Patient problems: Impaired Healing

  MAUDE report 9353216 ↗
• InjuryDec 13, 2018Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY TSA PROCEDURE ON HER RIGHT SHOULDER ON (B)(6) 2016. ABOUT 12 MONTHS POST-OP, THE PATIENT WAS EXPERIENCING CONSTANT PAIN IN HER SHOULDER. AFTER A YEAR OF PAIN, SHE WAS SEEN BY HER SURGEON AND WHEN AN X-RAY WAS TAKEN, IT REVEALED SHE HAD A FRACTURED HUMERUS. THE SURGEON DECIDED TO CONVERT TO AN RTSA. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 TO CONVERT FROM PRIMARY TSA TO RTSA AND DURING THE CASE, THE SURGEON FOUND THAT ONE OF THE FEET OF THE "TRUNION" (PART OF AR-9100-08S) WAS BROKEN AND THE INFERIOR PORTION OF THE GLENOID POLY (AR-9105-02) WAS SHOWED SIGNS OF WEAR. THE BROKEN FOOT WAS FOUND SECURED NEAR THE REST OF THE "TRUNION". THE FOLLOWING THREE DEVICES (ALONG WITH THE BROKEN FOOT) WERE EXPLANTED: AR-9100-08S / LOT: 1349709. AR-9105-02 / LOT: 113601502. AR-9144-17P / LOT: 150049215.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8160536 ↗
• InjuryMar 7, 2017Device Slipped

  IT WAS REPORTED FROM ADDITIONAL INFORMATION OBTAINED ON 02/09/17 THAT THIS INCIDENT OCCURRED AS A REVISION PROCEDURE. THE PATIENT HAD UNDERGONE AN APEX HEMI ARTHROPLASTY ON (B)(6) 2016 AT ANOTHER FACILITY. THE PATIENT WAS EXPERIENCING PAIN AND THE SURGEON THOUGHT THE APEX STEM, AR-9100-08S, LOT 1349710 ((B)(6) (B)(4)) WAS LOOSE. DURING THE (B)(6) 2017 REVISION, IT WAS CONFIRMED THAT THE STEM WAS LOOSE. THE STEM AND THE HUMERAL HEAD, AR-9150-19P, LOT 150058018 ((B)(6) (B)(4)) WERE BOTH EXPLANTED DURING THE REVISION. THE CASE WAS COMPLETED BY USING AN ARTHREX REVERSE PROCEDURE.

  Patient problems: Pain

  MAUDE report 6383360 ↗