MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS APEX STEM, SIZE 13; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	AR-9501-13S
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
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
On (b)(6) 2022, it was reported by a sales representative via email that an a patient underwent a reverse modular shoulder procedure on (b)(6) 2020.During this procedure an ar-9501-13s apex humeral stem, an ar-9502f-39lcpc suture cup, an ar-9503m-03 humeral insert, an ar-9560-28-4 modular baseplate, an ar-9561-35s central screw, an ar-9563-36 peripheral locking screw, an ar-9563-40 peripheral locking screw, and an ar-9564-2839-lat glenosphere, were successfully implanted.Two years later, on (b)(6) 2022, patient underwent a revision reverse total shoulder procedure because the central and peripheral screws broke off the baseplate.
Additional Manufacturer Narrative
The complaint is not confirmed based on the customer provided photo, which displays the intact stem with no defects.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: UNIVERS REVERS APEX STEM, SIZE 13
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 15615005
• Report Number: 1220246-2022-05619
• Device Sequence Number: 5798072
• Product Code: PHX
• UDI-Device Identifier: 00888867250543
• UDI-Public: 00888867250543
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: AR-9501-13S
• Device Catalogue Number: UNIVERS REVERS APEX STEM, SIZE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 10/26/2022
• 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: Unknown