MAUDE Adverse Event Report: ENCORE MEDICAL L.P. REVERSE PROSTHESIS SHOULDER SYSTEM; SOCKET, INSERT 32MM SEMI RSP HUMERAL

Model Number 508-01-032

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/10/2023

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - poly wear.

• Brand Name: REVERSE PROSTHESIS SHOULDER SYSTEM
• Type of Device: SOCKET, INSERT 32MM SEMI RSP HUMERAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 16491990
• MDR Text Key: 310771724
• Report Number: 1644408-2023-00230
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024693
• UDI-Public: 00888912024693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 508-01-032
• Device Catalogue Number: 508-01-032
• Device Lot Number: 859C1088
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 508-32-103 , LOT 864C2167
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female