MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - INLAY MEDIUM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERSAL GLENOID - INLAY MEDIUM
Medical Device Problem Codes	Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/29/2020
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.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 an aseptic loosening of the base plate.It was further reported that a screw broke caudal and inlay showed abrasion.The glenoid component was removed an a cerement filling was done.No further information received.17-apr-2023 update dw: further information were provided that an ar-9145-30 was the broken screw.
Additional Manufacturer Narrative
The investigation could not confirm the reported condition as the complaint device was not returned for evaluation and no additional information was provided.The post-op breakage and the abrasion found on the caudal attributes the most likely probable cause to post-op patient trauma.

• Brand Name: UNIVERSAL GLENOID - INLAY MEDIUM
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: 16838371
• Report Number: 1220246-2023-06619
• Device Sequence Number: 7547288
• Product Code: PHX
• UDI-Device Identifier: 00888867057425
• UDI-Public: 00888867057425
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K182039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: 02/28/2017
• Device Model Number: UNIVERSAL GLENOID - INLAY MEDIUM
• Device Catalogue Number: AR-9121-02
• Device Lot Number: 2501203203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 10/03/2023
• 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