MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS GLENO 36 +4 LAT; PHX SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS GLENO 36 +4 LAT
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/06/2020
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.
Event or Problem Description
It was reported that a shoulder revision surgery was needed as the implant became loose.The revision surgery was finished successfully.No further information provided.Updated information obtained 20-apr-2020: further information were provided that the initial surgery was performed on (b)(6) 2020 and the revision surgery was performed on (b)(6) 2020.The revision surgery was finished successfully with a new device with the same part number.
Additional Manufacturer Narrative
Complaint not confirmed.The device was returned free of damage and was found to meet dimensional specifications.A potential cause of dissociation is improper and/or incomplete mating of the taperlock feature due to interference from surrounding tissue.

• Brand Name: UNIVERS REVERS GLENO 36 +4 LAT
• Common Device Name: PHX SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10010714
• Report Number: 1220246-2020-01812
• Device Sequence Number: 14195088
• Product Code: PHX
• UDI-Device Identifier: 00888867061408
• UDI-Public: 00888867061408
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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 Expiration Date: 03/31/2024
• Device Model Number: UNIVERS REVERS GLENO 36 +4 LAT
• Device Catalogue Number: AR-9504S-04
• Device Lot Number: 19.00007
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/07/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other