MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SPACER 39+15MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS SPACER 39+15MM
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/10/2019
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.
Event or Problem Description
It was reported through the surgical outcome system that a patient complication occurred that was possibly related to an arthex product.Upon further investigation the following was discovered: patient underwent an (b)(6) 2019 shoulder procedure.The patient had a post-operative dislocation resulting in a (b)(6) 2019 revision surgery.During the revision procedure the following arthrex devices were explanted: ar-9503m-03c /humeral insert and ar-9505-15 /univers reverse spacer.To complete the revision procedure the surgeon implanted the following two arthrex devices: ar-9503m-06 /humeral insert and ar-9505-15 /univers reverse spacer.

• Brand Name: UNIVERS REVERS SPACER 39+15MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10934417
• Report Number: 1220246-2020-02376
• Device Sequence Number: 17217161
• Product Code: PHX
• UDI-Device Identifier: 00888867061453
• UDI-Public: 00888867061453
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/02/2020

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: UNIVERS REVERS SPACER 39+15MM
• Device Catalogue Number: AR-9505-15
• Device Lot Number: 120164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other