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

Model Number	GLENOID, PE WITH PEG, SMALL
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/28/2023
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that a revision surgery was necessary due to a broken and loosened pegged glenoid.The implants were initially implanted on (b)(4) 2014.It was further reported that the following devices were explanted in addition to the defective pegged glenoid: humeral head 43/18, ar-9343-18, 1295123602.Trunion 43, ar-9300-43cpc, 13.018.Cage screw small, ar-9301-01, 13.134.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in h6: type of investigation, investigation findings, investigation conclusions, and h10, and updated information in g1 and g3.The complaint is confirmed based on the customer provided photos, which shows the glenoid broken.The most likely cause for the reported failure can be attributed to wear and tear due to the normal wear after 10 years of friction of glenoid material and metal part from the surgery,.

• Brand Name: GLENOID, PE WITH PEG, SMALL
• 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: 18395438
• Report Number: 1220246-2023-09647
• Device Sequence Number: 2933086
• Product Code: KWS
• UDI-Device Identifier: 00888867057319
• UDI-Public: 00888867057319
• 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 Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GLENOID, PE WITH PEG, SMALL
• Device Catalogue Number: AR-9105-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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