MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, PE WITH PEG, MEDIUM; PROSTHESIS, SHOULDER, CEMENTED

Model Number	GLENOID, PE WITH PEG, MEDIUM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
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.Directions for use (dfu) dfu-0131 univers ii total shoulder system and univers apex total shoulder system.D.Adverse effects 3.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.Loosening is frequently a consequence of one or several of the above-listed risk conditions, but can also be caused by inadequate anchoring technique (see below).4.Dislocation, subluxation, or inadequate scope of movement as a result of failure to achieve optimum positioning of the implant.5.Bone fractures as a result of one-sided overload or weakened bone substance.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, MEDIUM
• Common Device Name: PROSTHESIS, SHOULDER, 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: emily shafer ; 8009337001
• MDR Report Key: 18002448
• Report Number: 1220246-2023-08359
• Device Sequence Number: 12422729
• Product Code: KWS
• UDI-Device Identifier: 00888867057326
• UDI-Public: 00888867057326
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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 Expiration Date: 06/15/2020
• Device Model Number: GLENOID, PE WITH PEG, MEDIUM
• Device Catalogue Number: AR-9105-02
• Device Lot Number: 113601502
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown