MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP MONOBLOCK SOCKET INSERT, 36MM +4MM, SEMICONSTRAINED, HXE-PLUS; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 509-01-436

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

Patient Problem Unspecified Infection (1930)

Event Date 12/05/2023

Event Type  Injury  

Event Description

Revision surgery - due to infection.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2019-00674; 509-01-436, s808 - infection, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: RSP MONOBLOCK SOCKET INSERT, 36MM +4MM, SEMICONSTRAINED, HXE-PLUS
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18422513
• MDR Text Key: 331664779
• Report Number: 1644408-2023-01916
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144667
• UDI-Public: 00888912144667
• 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: 12/29/2023

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 Catalogue Number: 509-01-436
• Device Lot Number: 390P1087
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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: 508-36-101 LOT: 869C3462
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male