Arthrex® AR-9105-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867057333), received between Mar 24, 2017 and Aug 8, 2024 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 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) 2016 A REVISION SURGERY OF THE LARGE PEGGED GLENOID WAS NECESSARY 6 MONTHS AFTER THE INITAL SURGERY DUE TO A GLENOID LOOSENING / CEMENT BREAKAGE. NO FURTHER INFORMATION RECEIVED. ***UPDATE (B)(6) 2024: FURTHER INFORMATION WAS PROVIDED THAT AFTER THE INITIAL IMPLANTATION OF AN AR-9105-03 ON (B)(6) 2016 THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2017.

  Patient problems: Failure of Implant

  MAUDE report 19937442 ↗
• MalfunctionApr 30, 2024Fitting Problem; Fitting Problem

  ON 10/28/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9105-03 GLENOID DIDN'T FIT AND THE AR-9561-20P CENTRAL POST WOULD NOT ENGAGE. THIS WAS DISCOVERED DURING USE IN A REVERSE ARTHROPLASTY ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-9105-03 AND AR-9561-20P.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212475 ↗
• 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. DURING THE REVISION SURGERY THE GLENOID WAS REMOVED, A GLENOID RECONSTRUCTION USING ALLOGRAFT WAS PERFORMED AND SHOULDER PROSTHESIS WAS CHANGED TO INVERSE. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378856 ↗
• InjuryJun 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SHOULDER SURGERY WAS PERFORMED DUE TO LOOSENING AND ABRASION OF THE GLENOID COMPONENT. UPDATE AVOE 06-JUN-2023. IT WAS FURTHER REPORTED THAT THE INITIAL SURGERY TOOK PLACE IN 2015 AT THE (B)(6). DURING THE REVISION SURGERY ON (B)(6) 2023 THE PATIENT WAS TREATED WITH A CONVERSION TO AN INVERSE ASCEND FROM STRYKER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170843 ↗
• InjuryFeb 6, 2023Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 16303015 ↗
• InjuryDec 27, 2021Therapeutic or Diagnostic Output Failure

  ON (B)(6) 2021, IT WAS REPORTED BY A SALE REPRESENTATIVE VIA THE PHONE THAT AR-9100-10S, AR-9146-18P AND AR-9105-03 WERE EXPLANTED (B)(6) 2021 DUE TO PAIN AND ROTATOR CUFF FAILURE CONFIRMED BY IMAGING. THESE DEVICES WERE IMPLANTED ON (B)(6) 2015 @ (B)(6) HOSPITAL. THE CASE WAS COMPLETED USING A COMPETITORS REVERSE TOTAL SHOULDER SYSTEM.

  Patient problems: Pain

  MAUDE report 13087685 ↗
• InjuryApr 1, 2020Loose or Intermittent Connection; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SHOULDER SURGERY WAS PERFORMED DUE TO AN ASEPTIC LOOSENING OF THE GLENOID. SUBSIDENCE WITH PE CONSUMPTION AND CLEAR GLENOID LYSIS. THE PROSTHESIS WAS REPLACED WITH AN INVERSE SHOULDER PROSTHESIS. THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2011. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9910343 ↗
• InjuryFeb 21, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SHOULDER SURGERY WAS PERFORMED ON (B)(6) 2019. THE GLENOID GOT LOOSE POST OP. NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER. THE DEVICE WILL NOT RETURN FOR INVESTIGATION.

  Patient problems: No Information

  MAUDE report 9738731 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2018 DUE TO AN NON-REPAIRABLE ROTATOR CUFF REPAIR. ADDITIONAL INFORMATION OBTAINED 11/7/18: THE PATIENT WAS PARTICIPATING IN AN ECLIPSE TSA STUDY PROGRAM. THE DEVICES LISTED BELOW WERE IMPLANTED ON (B)(6) 2016. THE SURGEON REPORTED THAT THE ROTATOR CUFF WAS TORN AND APPEARED TO BE FROM TRAUMA, BUT PATIENT DENIED. THE SUBJECT RECEIVED A REVERSE DEVICE AFTER THE ORIGINAL DEVICES WERE EXPLANTED. THE PATIENT SUBJECT WAS TERMINATED FROM THE STUDY UPON DEVICE REMOVAL. THE DEVICES WERE DISCARDED PRIOR TO ARTHREX BEING NOTIFIED AS IT WAS THOUGHT THAT THE DEVICES DID NOT NEED TO BE RETURNED AS THEY DID NOT FEEL IT WAS A DEVICE MALFUNCTION.

  Patient problems: Injury

  MAUDE report 8054594 ↗
• InjuryOct 24, 2018Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  A PATIENT REPORTED THAT ON (B)(6) 2016 HE UNDERWENT A SHOULDER REPLACEMENT SURGERY DURING WHICH ARTHREX A PATIENT REPORTED THAT ON (B)(6) 2016 HE UNDERWENT A SHOULDER REPLACEMENT SURGERY DURING WHICH ARTHREX PRODUCTS WERE IMPLANTED INTO HIS SHOULDER. PATIENT DEVELOPED AN INFECTION IN HIS SHOULDER AND ON (B)(6) 2016 THE SURGEON PERFORMED A PROCEDURE TO CLEAN OUT THE SURGICAL SITE. NO IMPLANTS WERE REMOVED AT THAT TIME. THE ISSUES WITH INFECTION CONTINUED AND ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION PROCEDURE AND REMOVED THE ORIGINAL ARTHREX PRODUCTS FROM PATIENT'S SHOULDER AND REPLACED THEM WITH NEW ARTHREX PRODUCTS. APPROXIMATELY 2 MONTHS AFTER THE (B)(6) 2016 PROCEDURE PATIENT BEGAN HAVING A RASH UNDER HIS ARMPIT THAT HAS NOT GONE AWAY. IN ADDITION PATIENT HAS SIGNIFICANT PAIN IN HIS SHOULDER. PATIENT HAD BEEN DOING REHAB SINCE THE (B)(6) 2016 SURGERY BUT RECENTLY STOPPED REHAB AS IT WAS NOT HAVING ANY EFFECT AND THE PAIN HAS CONTINUED ALONG WITH THE RASH. PATIENT'S SURGEON HAS RECOMMENDED ANOTHER SURGERY ON THIS SAME SHOULDER AND HAS PROPOSED DOING A REVERSE TOTAL SHOULDER PROCEDURE. PATIENT OBTAINED A SECOND OPINION FROM A SURGEON IN (B)(6) WHO CONCURRED THAT ANOTHER SURG

  Patient problems: Pain; Rash; Unspecified Infection

  MAUDE report 8002063 ↗
• InjuryJan 10, 2018Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL SHOULDER PROCEDURE ON (B)(6) 2014. THREE YEARS POST-OP, THE AR-9105-03, GLENOID, PE WITH PEG, LARGE, LOT 1432001 THAT WAS IMPLANTED BROKE. THE PATIENT UNDERWENT A SECOND SURGERY ON (B)(6) 2017 DURING WHICH THE BROKEN GLENOID WAS EXPLANTED. THE PEGS AND KEEL SEEMED TO HAVE SHEARED OFF. THERE WAS NO TRAUMATIC EVENT THAT CAUSED THE GLENOID TO FAIL (I.E. PATIENT FALLING). THE BROKEN GLENOID WAS REMOVED AND NO DEVICES WERE IMPLANTED. THE PEGS AND KEEL WERE RETRIEVED FROM THE PATIENT. SURGEON USED A GRASPER TO PULL THEM OUT. THE DEVICE WAS DISCARDED BY THE FACILITY. PICTURES OF THE DEVICE HAVE BEEN PROVIDED. THE SURGEON PERFORMED A ROUTINE ARTHROSCOPY TO REMOVE THE IMPLANT. SURGEON THEN LEFT THE PATIENT AS IS TO SEE IF THE PATIENT COULD MANAGE WITHOUT ANOTHER OPEN PROCEDURE. FOLLOW-UP INVESTIGATION: THE PATIENT CAME BACK IN (B)(6) 2017 TO HAVE A REVISION TSA. DURING THE (B)(6) 2017 REVISION TSA THE SURGEON HAD TO EXPLANT THE ORIGINAL AR-9154-21P, USP II HUMERAL HEAD, LOT 2501401412, AND THE TRUNION PORTION OF THE ORIGINAL AR-9100-10S, UNIVERS APEX HUMERAL STEM, LOT 1192182. THIS WAS TO GAIN ACCESS TO BE ABLE TO IMPLANT A NEW GLENOID. THE

  Patient problems: Failure of Implant

  MAUDE report 7178419 ↗
• InjurySep 12, 2017Torn Material

  IT WAS REPORTED THAT THE PATIENT TORE THE ROTATOR CUFF AND REQUIRED IMPLANT REMOVAL AND REVERSE SHOULDER SYSTEM.

  Patient problems: No Code Available

  MAUDE report 6860661 ↗
• InjuryMar 24, 2017Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT HAD ORIGINAL ECLIPSE SURGERY IN 2013. GLENOID AR-9105-03, (LOT 1230011) (CC108390 LINE 186146), SCREW-AR-9301-02, (LOT 1127024) (CC108390 LINE 187579), TRUNION-AR-9300-49CPC, (LOT 1128006) (CC180390 LINE 187581), HUMERAL HEAD- AR-9349-18, (LOT 947018) (CC180390 LINE 187584) WERE IMPLANTED. FOLLOW-UP SERIAL X RAYS SHOWED INCREASING LUCENT LINES AROUND THE PEGGED GLENOID. PATIENT HAD PAIN AND DECISION WAS MADE TO REVISE TO A REVERS PER SURGEON. REVISION TOOK PLACE ON (B)(6) 2017. THE HUMERAL COMPONENT WAS REMOVED WITHOUT ISSUE. SALES REP NOTED THAT THE ECLIPSE PROSTHESIS WAS EXTREMELY WELL FIXED AND THE CAGE SCREW HAD COMPLETE BONE THROUGH GROWTH. THE GLENOID WAS LOOSE AND WAS REMOVED BY HAND WITH PEGS INTACT. CEMENT WAS REMOVED FROM THE GLENOID. AUTOGRAFT WAS TAKEN FROM THE ILIAC CREST TO ADDRESS THE BONE DEFECT IN THE GLENOID. THE ALLOGRAFT WAS PREPARED FOR THE REVERS BASE PLATE IN SITU PRIOR TO HARVESTING THE GRAFT. THE BASEPLATE WAS THEN TRIED TO MATCH THE BONE DEFECT. THE BONE GRAFT AND BASE PLATE WERE IMPLANTED AND FIXATED WITH THE BASEPLATE SCREWS. THE REST OF THE REVERS SURGICAL TECHNIQUE WAS FOLLOWED TO COMPLETE THE CASE. PATIENT WAS A (B)(6) MAL

  Patient problems: Pain

  MAUDE report 6431855 ↗