Arthrex® AR-9100-06SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867134416), received between Jun 22, 2017 and Jul 25, 2024 — classified as 7 injuries, 3 malfunctions.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2024Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ON 7/8/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY WILL UNDERGO REVISION SURGERY DUE TO BONE FRACTURES IN THE TARGET SHOULDER. THIS EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS APEX DEVICES IMPLANTED ON (B)(6) 2017. ON (B)(6) 2024, THE PATIENT RETURNED TO THE CLINIC FOR A ROUTINE SEVEN-YEAR FOLLOW-UP AS PART OF CLINICAL STUDY REQUIREMENTS. UPON REVIEW OF THE RADIOGRAPHS, RADIOLUCENT LINES AROUND THE IMPLANTED AR-9100-06S UNIVERS APEX HUMERAL STEM 6 MM, WERE DISCOVERED, SIGNIFYING IMPENDING FRACTURE OR HUMERAL STEM LOOSENING. A REVISION ARTHROPLASTY SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2024.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 19827629 ↗
• MalfunctionJun 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE AR-9100-06S UNIVERS APEX HUMERAL STEM IMPLANT WAS INSERTED AS PER THE TECHNIQUE. THE THREADS WOULD NOT PROPERLY "SEAT" THE IMPLANT FOR PROPER POSITIONING. A SECOND IMPLANT WAS USED AND INSERTED IN THE PROPER POSITION. NO ADDITIONAL TIME OR ADVERSE ACTION WAS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 19519059 ↗
• MalfunctionApr 24, 2024Connection Problem; Connection Problem

  IT WAS REPORTED DURING A TSA PROCEDURE YESTERDAY THE AR-9100-06S 6MM APEX STEM WAS FAULTY. THE INCLINATION ADJUSTMENT ON THE STEM WOULD NOT FREE ADJUST EVEN WHEN THE INFERIOR SCREW WAS LOOSENED. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE BY USING A SECOND STEM. THE REP EXAMINED THE FAULTY STEM AFTER THE PROCEDURE AND IT WAS CLEAR THAT THE STEM IS FROZEN AT FULL INCLINATION. SEE ATTACHED IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172480 ↗
• MalfunctionApr 11, 2024Fitting Problem; Fitting Problem

  ON 4/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9140-17P HUMERAL HEAD WOULD NOT SEAT. SURGEON HAD USED A TRIAL STEM PREVIOUSLY, WHICH SEATED CORRECTLY BEFORE USING THE IMPLANT. THIS WAS DISCOVERED DURING A TSA PROCEDURE ON (B)(6)2022. ADDITIONAL INFORMATION RECEIVED ON 4/14/2022: NOTHING BROKE INSIDE THE PATIENT AND CASE WAS COMPLETED USING AN AR-9106-01 VAULTLOCK GLENOID AND AN AR-9207S PIN SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089509 ↗
• InjuryApr 7, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A PATIENT HAD A REVISION SURGERY. THE ORIGINAL SURGERY DATE WAS (B)(6) 2019. THE PATIENT FELL ON (B)(6) 2020 AND SUFFERED FROM A ROTATOR CUFF TEAR. THIS WAS THE PURPOSE OF THE REVISION. THE FOLLOWING PARTS WERE REMOVED AR-9100-06S, AR-9146-18P AND AR-9106-02. THE TOTAL SHOULDER REPLACEMENT WAS REMOVED AND REPLACED TODAY. MALE PATIENT (B)(6) YEARS OF AGE. THE REVISION CASE WAS COMPLETED AND THE PATIENT IS NOW FINE TO DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall

  MAUDE report 11626985 ↗
• InjuryOct 17, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT MAY HAVE HAD AN ISSUE AS A RESULT OF SURGERY INVOLVING ARTHREX IMPLANTS. UPON FURTHER INVESTIGATION IT WAS DISCOVERED THAT A PATIENT HAD A (B)(6) 2018 TOTAL SHOULDER ARTHROPLASTY PROCEDURE. ON (B)(6) 2018, A FEW DAYS POST SURGERY, THE PATIENT WAS EXPERIENCING INABILITY TO EXTEND FINGERS. THE PATIENT WAS DIAGNOSED WITH RADIAL NERVE PALSY. PATIENT WAS ABLE TO EXTEND WRIST ON (B)(6) 2019 BUT HAD DIFFICULTY TYPING. AN EMG WAS RECOMMENDED. PATIENT WAS TOLD NERVE PALSY WOULD RESOLVE WITHIN THE YEAR. THE PATIENT CONSULTED WITH AN ORTHOPEDIC HAND SURGERY SPECIALIST WHO SUGGESTED A TENDON TRANSFER FOR THE NERVE PALSY. IT IS UNKNOWN IF THE PATIENT HAS PROCEEDED WITH A SECOND SURGERY WITH ANOTHER SURGEON. THE PATIENT HAS HAD NO FURTHER SURGERIES WITH THE ORIGINAL SURGEON. THE FOLLOWING ARE THE ARTHREX PRODUCTS THAT WERE IMPLANTED (B)(6) 2018: AR-9100-06S / LOT: 10233337. AR-9106-01 / LOT: 1027261806. AR-9142-17P / LOT: 170097421.

  Patient problems: Loss of Range of Motion; No Code Available

  MAUDE report 10694532 ↗
• 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 10483845 ↗
• InjuryDec 13, 2018Break

  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 8160802 ↗
• InjuryDec 12, 2018Break; Migration or Expulsion 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: Foreign Body In Patient

  MAUDE report 8155060 ↗
• InjuryJun 22, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2014. IN (B)(6) 2014, THE PATIENT BEGAN TO EXPERIENCE LAXITY IN THE SHOULDER. ON (B)(6) 2017, A REVISION REVERS TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED WHERE THE PREVIOUSLY IMPLANTED UNIVERS APEX 6MM HUMERAL STEM (AR-9100-06S, LOT: 974810, LINE 195553), SMALL GLENOID W/ PEG (AR-9105-01, LOT: 1329015, (B)(4)) AND USP II HUMERAL HEAD (AR-9144-17P, LOT: 2501356510, (B)(4)) WERE EXPLANTED AND REPLACED WITH ARTHREX REVERS TOTAL SHOULDER PARTS.

  Patient problems: Failure of Implant

  MAUDE report 6661143 ↗