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

Catalog Number 509-01-036

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 03/14/2024

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 - due to instability.

• Brand Name: RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 36MM, 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: 19102529
• MDR Text Key: 340106233
• Report Number: 1644408-2024-00484
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144629
• UDI-Public: 00888912144629
• 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: 04/12/2024

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: 509-01-036
• Device Lot Number: 382P1183
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/13/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 869C3953
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male