Arthrex® AR-9105-02Recalls & reported problems
Arthrex, Inc. · GLENOID, PE WITH PEG, MEDIUM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex AR-9105-02 is a medium pegged polyethylene glenoid implant used in shoulder replacement surgery. The 31 reports mostly describe the glenoid component loosening in the shoulder socket, often leading to pain, joint looseness, and revision surgery to remove and replace the implant; a few mention parts breaking or detaching. No deaths were reported, and 29 injuries were. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00888867057326), received between Apr 6, 2017 and Aug 8, 2024 — classified as 29 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (14 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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth14
- Appropriate Device Problem Term/Code Not Available7
- Loose or Intermittent Connection6
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Detachment Of Device Component2
- Naturally Worn2
- Defective Component1
Patient problems
- Failure of Implant14
- Pain4
- No Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information2
- Joint Laxity2
- No Code Available2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 31 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) 2012 A REVISION SURGERY OF THE MEDIUM PEGGED GLENOID WAS NECESSARY AFTER MAY 2017 DUE TO A GLENOID LOOSENING. NO FURTHER INFORMATION RECEIVED. UPDATE DW 06-AUG-2024: FURTHER INFORMATION WAS PROVIDED THAT THE REVISION SURGERY OF THE AR-9105-02 WITH THE LOT 1147008, WHICH WAS IMPLANTED ON (B)(6) 2012, WAS PERFORMED ON (B)(6) 2017.
Patient problems: Failure of Implant
MAUDE report 19937506 ↗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) 2015 A REVISION SURGERY OF THE MEDIUM PEGGED GLENOID WAS NECESSARY 2021 DUE TO A GLENOID LOOSENING. NO FURTHER INFORMATION RECEIVED. ***UPDATE DW 05-AUG-2024: FURTHER INFORMATION WAS PROVIDED THAT THE AR-9105-02 WITH THE BATCH 1414005 WAS IMPLANTED ON (B)(6) 2015 AND THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021.
Patient problems: Failure of Implant
MAUDE report 19931697 ↗InjuryJan 8, 2024Loosening 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 LOOSENING GLENOID COMPONENT. THE GLENOID WAS REMOVED AND A GLENOID AUGMENTATION USING ALLOGRAFT WAS PERFORMED. THE SHOULDER PROSTHESIS WAS REPLACED TO INVERSE TOTAL SHOULDER ARTHROPLASTY. NO FURTHER INFORMATION RECEIVED.
Patient problems: Failure of Implant
MAUDE report 18463519 ↗InjuryNov 10, 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 LOOSENING GLENOID COMPONENT. THE GLENOID WAS REMOVED AND A GLENOID RECONSTRUCTION USING ALLOGRAFT AND SHOULDER PROSTHESIS CHANGE TO INVERSE TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED. NO FURTHER INFORMATION RECEIVED.
Patient problems: Failure of Implant
MAUDE report 18110131 ↗InjuryNov 10, 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 LOOSENING GLENOID COMPONENT. THE GLENOID WAS REMOVED AND A GLENOID RECONSTRUCTION USING ALLOGRAFT AND SHOULDER PROSTHESIS CHANGE TO INVERSE TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED. NO FURTHER INFORMATION RECEIVED.
Patient problems: Failure of Implant
MAUDE report 18110074 ↗InjuryOct 25, 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 LOOSENING GLENOID COMPONENT. A CONSTRUCTION OF THE GLENOID WITH ALLOGRAFT AND A SHOULDER PROSTHESIS CHANGE TO AN INVERSE SHOULDER PROSTHESIS WAS PERFORMED. NO FURTHER INFORMATION RECEIVED.
Patient problems: Failure of Implant
MAUDE report 18002448 ↗MalfunctionOct 25, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED AND THE PROSTHESIS WAS REMOVED. A GLENOID CONSTRUCTION WITH ALLOGRAFT WAS PERFORMED AND A SHOULDER PROSTHESIS CHANGE TO AN INVERSE SHOULDER PROSTHESIS IS PLANNED FOR THE NEXT SURGERY. NO FURTHER INFORMATION RECEIVED.
Patient problems: Failure of Implant
MAUDE report 18001872 ↗InjuryJul 31, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A TWO SIDED REVISION SURGERY WAS PERFORMED DUE TO A LOOSENING OF THE GLENOID. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17423800 ↗InjuryJun 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC GLENOID COMPONENT LOOSENING AND A CLEAR GLENOID DEFECT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED WITH A GLENOID RECONSTRUCTION WITH ALLOGRAFT AND THE SHOULDER PROSTHESIS WAS CHANGED TO AN INVERSE SHOULDER PROSTHESIS.
Patient problems: Failure of Implant
MAUDE report 17037337 ↗InjuryOct 11, 2022Loosening 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 CHANGED TO AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION RECEIVED.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 15576298 ↗InjuryJul 18, 2022Defective Component; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A MASSIVE GLENOID POLYETHYLENE LOOSENING WITH LOSS OF SUBSTANCE AND NON-CONTAINED DEFECT OF THE GLENOID. DUE TO THIS FAILURE A PROSTHESIS REMOVAL AND GLENOID RECONSTRUCTION WITH ALLOGRAFT WAS NECESSARY. NO FURTHER INFORMATION RECEIVED.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 15041987 ↗InjuryJan 31, 2022Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY OF THE PEGGED GLENOID WAS NECESSARY. NO FURTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THAT A REVISION SURGERY OF THE PEGGED GLENOID WAS NECESSARY. NO FURTHER INFORMATION WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 13395002 ↗InjuryDec 7, 2021Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2021, IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT EXPERIENCED AN ADVERSE EVENT UNDERGOING A SHOULDER ARTHROPLASTY PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 10/26/2021: THE DATE OF THE PRIMARY PROCEDURE WAS (B)(6) 2015 FOR A SHOULDER ARTHROPLASTY. THIS PROCEDURE TOOK PLACE AT (B)(6) ORTHOPEDIC, ARTHREX ACCOUNT #(B)(4) ON (B)(6) 2015. A COMPLICATION WAS REPORTED ON 05/25/2021 AND THE DATE OF THE SECONDARY PROCEDURE WAS ON (B)(6) 2021. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 11/12/2021 : THE DATE OF THE REVISION SURGERY WAS ON (B)(6) 2021. THE PATIENT HAD PAIN THAT BEGAN ABOUT FIVE AND A HALF YEARS POST OPERATIVE, AND CONTINUED TO INCREASE AFFECTING THE QOL AND THEREFOR LEADING TO THIS REVISION. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 11/19/2021 THE FOLLOWING EXPLANTED DEVICE NUMBERS WERE PROVIDED: AR-9100-10S LOT#1349768; AR-9105-02 LOT #1503005; AR-9148-17 LOT #2501448207.
Patient problems: Pain
MAUDE report 12954018 ↗InjuryJul 27, 2021Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A REVISION SHOULDER SURGERY HAD TO BE PERFORMED DUE TO AN ASEPTIC LOOSENING OF THE DEVICE. THE PATIENT WAS TREATED WITH A CONVERSION TO HEMI SHOULDER PROSTHESIS. THE DEVICE WAS REMOVED AND THE GLENOID DEFECT WAS FILLED WITH CERAMENT. NO FURTHER INFORMATION RECEIVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12231675 ↗InjuryJan 5, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY APPROXIMATELY 6 YEARS AGO. THE X-RAY SHOWED THE PE GLENOID DISLOCATED INFERIORLY. THE REVISION SURGERY WAS PERFORMED WITH A DEVICE FROM ANOTHER MANUFACTURER. UPDATE 23-DEC-2020: THE REVISION SURGERY OF THE ECLIPSE TOOK PLACE ON (B)(6) 2020.
Patient problems: Insufficient Information
MAUDE report 11117130 ↗InjuryDec 14, 2020Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE OF LOOSENING OF POLYETHYLENE GLENOID WITH DESTRUCTION OF LOCAL GLENOID.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11003956 ↗MalfunctionNov 4, 2020Loose or Intermittent Connection
IT WAS REPORTED THAT THE PEG GLENOID AR-9105-02 BECAME LOOSE THROUGH ABRASION. THE FOLLOWING COMPONENTS ARE INVOLVED. AR-9102-02 W. BATCH UNK. AR-9300-43CPC W. BATCH 12315. AR-9301-02 W. BATCH 12537. AR-9343-16 W. BATCH 11295131006. DEVICES WILL BE RETURNED FOR INVESTIGATION, THEREFORE, REVISION SURGERY HAS BEEN PERFORMED. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 10786967 ↗InjuryJul 28, 2020Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A REVISION SURGERY OF AN ARTHREX ECLIPSE SHOULDER PROSTHESIS TO AN INVERSE PROSTHESIS HAD BEEN PERFORMED. REASON OF THE REVISION WAS AN INSUFFICIENCY OF THE ECLIPSE PROSTHESIS AFTER SEVERAL ROTATOR CUFF REPAIR SURGERIES. NO LOOSENING OF THE ECLIPSE OR THE GLENOID WERE OBSERVED, NO LOOSENING OF THE IMPLANTS. ACCORDING TO THE REPORTER, THE PATIENT HAD NO PROBLEMS WHICH COULD BE ATTRIBUTED TO THE IMPLANTED ECLIPSE PROSTHESIS ONLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10333298 ↗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 6/2/2020: REVISION SURGERY IS SCHEDULED TO TAKE PLACE (B)(6) 2020. ADDITIONAL INFORMATION PROVIDED 6/26/2020: 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 1456
Patient problems: Rupture
MAUDE report 10279520 ↗InjuryApr 1, 2020Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A REVISION SHOULDER SURGERY WAS PERFORMED DUE TO A GLENOID COMPONENT DETACHMENT. LOOSENING OF POLYETHYLENE ON THE GLENOID. REMOVAL OF THE ECLIPSE PROSTHESIS AND CONVERSION TO AN INVERSE SHOULDER PROSTHESIS WITH DONOR BONE AUGMENTATION. THE INITIAL SURGERY TOOK PLACE (B)(6) 2015. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Failure of Implant; No Code Available
MAUDE report 9910360 ↗InjuryFeb 21, 2020Loose or Intermittent Connection
IT WAS REPORTED THAT A REVISION SHOULDER SURGERY WAS PERFORMED ON THE (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: Failure of Implant
MAUDE report 9738857 ↗InjuryFeb 21, 2020Loose or Intermittent Connection; Naturally Worn; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A REVISION SHOULDER SURGERY ON THE RIGHT SHOULDER WAS PERFORMED ON (B)(6) 2019. THE GLENOID GOT LOOSE AND WORN POST OP. NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER. THE DEVICE WILL NOT RETURN FOR INVESTIGATION.
Patient problems: No Information
MAUDE report 9738821 ↗InjuryFeb 21, 2020Loose or Intermittent Connection; Naturally Worn; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A REVISION SHOULDER SURGERY WAS PERFORMED ON (B)(6) 2017 AS THE GLENOID BECAME LOOSE /WORN. NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER. THE DEVICE WILL NOT RETURN FOR INVESTIGATION.
Patient problems: No Information
MAUDE report 9738767 ↗InjuryFeb 21, 2020Material Rupture; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A REVISION SHOULDER SURGERY WAS PERFORMED ON (B)(6) 2016 FOR AN INITIAL SECONDARY ROTATOR CUFF RUPTURE AS GLENOID COMPONENT BECAME LOOSE. NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER. THE DEVICE WILL NOT RETURN FOR INVESTIGATION.
Patient problems: No Code Available
MAUDE report 9738700 ↗InjuryFeb 21, 2020Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A REVISION SHOULDER SURGERY WAS PERFORMED ON (B)(6) 2012 AS A LOW GRADE INFECTION WAS IDENTIFIED AND THE GLENOID BECAME LOOSE. NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER. THE DEVICE WILL NOT RETURN FOR INVESTIGATION.
Patient problems: Unspecified Infection
MAUDE report 9738634 ↗
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- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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