Arthrex® AR-9105-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00888867057319), received between Nov 9, 2016 and Sep 20, 2024 — classified as 56 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (33 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 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Break; Break

  UPDATE (B)(6) 24-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE CUSTOMER HAS REMOVED THE GLENOID ARTHROSCOPIC. IT WAS THEN FURTHER REPORTED THAT DUE TO AN OMARTHROSE AN ADDITIONAL SURGERY WAS PERFORMED AND AN INVERSE SHOULDER-TEP WAS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20266271 ↗
• MalfunctionAug 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER AN INITIAL ECLIPSE SURGERY IN (B)(6) 2013 A REVISION SURGERY OF THE SMALL PEGGED GLENOID WAS NECESSARY AFTER (B)(6) 2023 DUE TO A GLENOID LOOSENING. NO FURTHER INFORMATION RECEIVED. ***UPDATE DW 05-AUG-2024: FURTHER INFORMATION WAS PROVIDED THAT THE AR-9105-01 WITH THE LOT 1215007 WAS IMPLANTED ON (B)(6) 2013. IT WAS FURTHER REPORTED THAT THE GLENOID LOOSENING WAS DIAGNOSED BUT NO REVISION SURGERY TOOK PLACE BY NOW.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19932340 ↗
• InjuryAug 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER AN INITIAL ECLIPSE SURGERY IN (B)(6) 2014 A REVISION SURGERY OF THE SMALL PEGGED GLENOID WAS NECESSARY IN (B)(6) 2023 DUE TO A GLENOID LOOSENING. NO FURTHER INFORMATION RECEIVED. ***UPDATE DW 05-AUG-2024: FURTHER INFORMATION WERE PROVIDED THAT AN AR-9105-01 WITH THE LOT 1419021 WAS IMPLANTED ON (B)(6) 2014 AND THE REVISION SURGERY TOOK PLACE ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 19931896 ↗
• InjuryDec 26, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A BROKEN AND LOOSENED PEGGED GLENOID. THE IMPLANTS WERE INITIALLY IMPLANTED ON (B)(4) 2014. IT WAS FURTHER REPORTED THAT THE FOLLOWING DEVICES WERE EXPLANTED IN ADDITION TO THE DEFECTIVE PEGGED GLENOID: HUMERAL HEAD 43/18, AR-9343-18, 1295123602. TRUNION 43, AR-9300-43CPC, 13.018. CAGE SCREW SMALL, AR-9301-01, 13.134.

  Patient problems: Failure of Implant

  MAUDE report 18395438 ↗
• InjuryJul 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A GLENOID COMPONENT LOOSENING. THE PATIENT WAS TREATED WITH A GLENOID RECONSTRUCTION USING ALLOGRAFT AND A SHOULDER PROSTHESIS CHANGE TO INVERSE TOTAL SHOULDER ARTHROPLASTY.

  Patient problems: Failure of Implant

  MAUDE report 17379584 ↗
• InjuryJun 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A MASSIVE GLENOID LOOSENING WITH GLENOID CYST FORMATION. THE PATIENT WAS TREATED WITH A CHANGE OF SHOULDER THE PROSTHESIS TO INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Cyst(s)

  MAUDE report 17172758 ↗
• InjuryMay 18, 2023Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AN EVENT OCCURRED WHICH RESULTED IN A STATIONARY TREATMENT AND AND ADDITIONAL ONE WILL BE NECESSARY. NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER. ON 26-APR-2023 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC LOOSENING OF THE GLENOID COMPONENT WITH A LOSS OF BONE SUBSTANCE. PROSTHESIS REMOVAL AND GLENOID AUGMENTATION WITH ALLOGRAFT WAS PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 16952672 ↗
• InjuryApr 28, 2023Defective Device; Loosening of Implant Not Related to Bone-Ingrowth; Defective Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AN REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC LOOSENING OF THE DEVICE. THE SHOULDER PROSTHESIS WAS CHANGED TO AN INVERSE SHOULDER PROSTHESIS. NO INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: Failure of Implant

  MAUDE report 16838628 ↗
• InjuryMar 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC LOOSENING OF THE GLENOID COMPONENT WITH ABRASION AND SUPRASPINATUS RUPTURE. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: Failure of Implant

  MAUDE report 16477148 ↗
• InjuryMar 2, 2023Loose or Intermittent Connection; Material Integrity Problem; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY IS NECESSARY DUE TO AN ASEPTIC LOOSENING OF THE GLENOID AND A POLYETHYLENE GRANULOME ABRASION. THE PROSTHESIS WAS REPLACED TO AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16466254 ↗
• InjuryMay 9, 2022Break; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC LOOSENING. IT WAS FURTHER REPORTED THAT THE GLENOID WAS SUB-TOTALLY ABRADED, MACROSCOPICALLY LOOSE AND ONE CRANIAL PEG WAS FOUND TO BE BROKEN. THEREFORE THE SHOULDER PROSTHESIS WAS REPLACED WITH AN INVERSE SHOULDER PROSTHESIS.

  Patient problems: Failure of Implant

  MAUDE report 14337404 ↗
• InjuryJan 11, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC LOOSENING OF THE GLENOID. THE SHOULDER PROSTHESIS WAS REVISED TO AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 13225456 ↗
• InjuryJan 4, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN ASEPTIC LOOSENING AND BECAUSE THE PATIENT FELL. THE SHOULDER PROSTHESIS WAS REVISED TO AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Fall

  MAUDE report 13154065 ↗
• InjuryJan 4, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN ASEPTIC LOOSENING AND BECAUSE THE PATIENT FELL. THE SHOULDER PROSTHESIS WAS REVISED TO AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Fall

  MAUDE report 13152701 ↗
• MalfunctionNov 30, 2021Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TOO ABRASION AND AN ASEPTIC LOOSENING. THE SHOULDER PROSTHESIS WAS REPLACED WITH AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION WERE PROVIDED.

  Patient problems: Abrasion; Failure of Implant

  MAUDE report 12897069 ↗
• InjuryOct 26, 2021Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF A PE-GLENOID WAS NECESSARY. NO INFORMATION PROVIDED BY THE CUSTOMER.

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

  MAUDE report 12697250 ↗
• InjuryOct 5, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN ASEPTIC LOOSENING OF THE DEVICE. THE PATIENT WAS TREATED WITH A SHOULDER PROSTHESIS CHANGE TO AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12576497 ↗
• InjuryAug 3, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO AN ASEPTIC LOOSENING OF THE DEVICE. DURING THE REVISION SURGERY THE PATIENT WAS TREATED BY REMOVING THE GLENOID IMPLANT AND FILLING THE BONE DEFECT WITH CEREMENT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12268128 ↗
• InjuryJun 7, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A ASEPTIC LOOSENING OF THE GLENOID. THE SHOULDER PROSTHESIS WAS CHANGED TO AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION RECEIVED. ON 20-MAY-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL IMPLANTATION WAS PERFORMED ON (B)(6) 2016. DURING THE REVISION IT WAS FOUND THAT THE ROTATOR CUFF WAS INTACT AND THAT THERE WAS NO SIGN OF AN INFECTION OR OTHER MORPHOLOGY OF THE BONE. THE PATIENT HAD A STRAIN ACTIVE LIFE STYLE AND WORK. THE PATIENT WAS TREATED WITH A TORNIER AEQUALIS REVERSED II WITH A GLENOID STRUCTURE.

  Patient problems: Failure of Implant

  MAUDE report 11947845 ↗
• MalfunctionMay 10, 2021Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A ASEPTIC LOOSENING OF THE PE GLENOID. THE GLENOID WAS RETRIEVED AND THE PATIENT WAS TREATED WITH A FILLING OF BONE SUBSTITUTE CEMENT (HEMI). IT WAS FURTHER REPORTED THAT THE ROTATOR CUFF WAS INTACT AND THAT NO INFECTION OR OTHER MORPHOLOGY OF THE BONE WAS IDENTIFIED. THE PATIENT SUFFERED INCREASING PAIN RESTRICTION OF MOVEMENT. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2014.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11798568 ↗
• MalfunctionApr 5, 2021Loose or Intermittent Connection

  IT WAS REPORTED THAT A GLENOID COMPONENT REMOVAL HAD TO BE PERFORMED AS A REVISION SURGERY DUE TO AN ASEPTIC LOOSENING OF THE DEVICE. NO FURTHER INFORMATION RECEIVED. UPDATE 31-MAR-2021: FURTHER INFORMATION WAS RECEIVED. X-RAYS AND PICTURES WERE PROVIDED CONTAINING THE PART- AND LOT-NO. OF ALL INVOLVED DEVICES (AR-9105-01/LOT 1246018, AR-9301-02/LOT 2501252307, AR-9300-41CPC/LOT 2501241206, CD-9341-16/1242003), WHICH WERE PRIMARY IMPLANTED ON THE (B)(6) 2013. THE DATE OF INCIDENT WAS CONFIRMED TO BE THE (B)(6) 2021 ALTHOUGH THE PATIENT HAS EXPERIENCED THE CORRESPONDINGLY LARGE BURDEN ON HER SHOULDERS ALREADY FOR MANY YEARS, BUT HAD TO CARE FOR HER SEVERELY DISABLED HUSBAND. AFTER THE HUSBAND PASSED AWAY, THE PATIENT DECIDED TO HAVE THE OPERATION. DURING THE REVISION A FILLING WITH BONE SUBSTITUTE CERAMENT (HEMI) WAS PERFORMED TO TREAT THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11612657 ↗
• MalfunctionJan 27, 2021Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A LOOSENING OF THE GLENOID COMPONENT AND A CENTRAL GLENOID DEFECT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 11235363 ↗
• MalfunctionSep 2, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE GLENOID GOT LOOSE. IT WAS REMOVED DURING A REVISION SURGERY AND THE BONE DEFECT WAS FILLED UP ON THE HUMERAL AND GLENOIDAL SIDE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10482456 ↗
• InjuryAug 24, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PEGGED GLENOID WAS REMOVED AFTER IT BECAME LOOSE. THE GLENOID WAS THEN RE-MODELED WITH BONE REPLACEMENT MATERIAL, RESULTING IN A HEMI-PROSTHESIS. AT THE MOMENT, NO MORE INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10443068 ↗
• InjuryJul 22, 2020Defective Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT LOOSENING AND BREAKAGE OF THE GLENOID COMPONENT DUE TO PE ABRASION OCCURRED. REVISION SURGERY PERFORMED WITH PROSTHESIS REMOVAL, IMPLANTATION OF AN INVERSE SHOULDER PROSTHESIS ON THE RIGHT FROM A DIFFERENT MANUFACTURER. INTRAOPERATIVELY, DEFECT OF THE GLENOID WAS CONFIRMED. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2013, DATE OF REVISION SURGERY WAS (B)(6) 2020. MALE PATIENT, YOB: 1943. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. FURTHER QUESTIONS BEING ASKED. ADDITIONAL INFORMATION OBTAINED 13-JUL-2020: THE PATIENT SUFFERED FROM PAIN AND WENT TO THE HOSPITAL, NO KNOWN TRAUMA THAT COULD HAVE CAUSED THE PAIN. PATIENT DOES NOT HAVE AN EXTRAORDINARILY HIGH BMI OR ANY KNOWN EXTRAORDINARILY STRESS. ADDITIONAL INFORMATION OBTAINED 27-OCT-2020: THE PART NUMBERS OF THE EXPLANTED ARTHREX DEVICES HAS BEEN PROVIDED AND ARE AS FOLLOWS: AR-9105-01 W/ BATCH 1221011. AR-9343-16 W/ BATCH 1295122004. AR-9300-43CPC W/ BATCH 12.055. AR-9301-02 W/ BATCH 12.363.

  Patient problems: Abrasion; Pain

  MAUDE report 10308170 ↗