MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, PE WITH PEG, LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	GLENOID, PE WITH PEG, LARGE
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause.The reported failure is most likely due to a patient-specific event, particularly the loosening of the implant as a result of changed conditions in load transfer, respectively, fatigue wear and breakage of the cement bed, and/or tissue reaction to the implant.The complaint was confirmed based on the attached pictures and the received devices.Due to the biohazard condition, they were unable to be physically and visually evaluated.

• Brand Name: GLENOID, PE WITH PEG, LARGE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 9910343
• Report Number: 1220246-2020-01772
• Device Sequence Number: 3130909
• Product Code: KWS
• UDI-Device Identifier: 00888867057333
• UDI-Public: 00888867057333
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GLENOID, PE WITH PEG, LARGE
• Device Catalogue Number: AR-9105-03
• Device Lot Number: 1032011
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male