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

Model Number	GLENOID, PE WITH PEG, LARGE
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: GLENOID, PE WITH PEG, LARGE
• 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: jared engle ; 8009337001
• MDR Report Key: 19937442
• Report Number: 1220246-2024-07081
• Device Sequence Number: 12592553
• Product Code: KWS
• UDI-Device Identifier: 00888867057333
• UDI-Public: 00888867057333
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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