MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS STEM S. 5 MONOBLOCK 135; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS REVERS STEM S. 5 MONOBLOCK 135
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that surgeon was implanting stem for reverse shoulder and the stem was loose.Had to open a 2nd stem and this one was not used.No adverse effect to the patient.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Since the complaint device was not returned, a physical evaluation of the device was not performed.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, the reported event is not confirmed without the device being returned or any photos provided.

• Brand Name: UNIVERS REVERS STEM S. 5 MONOBLOCK 135
• 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: 19486332
• Report Number: 1220246-2024-05289
• Device Sequence Number: 12743736
• Product Code: PHX
• UDI-Device Identifier: 00888867060975
• UDI-Public: 00888867060975
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• 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
• Report Date (Section B): 06/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: UNIVERS REVERS STEM S. 5 MONOBLOCK 135
• Device Catalogue Number: AR-9501-05-135CPC
• Device Lot Number: 170008313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2017
• 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
• Patient Sex: Unknown