MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP MONOBLOCK SOCKET INSERT, 32MM +4MM, SEMICONSTRAINED, HXE-PLUS; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 509-01-432

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

Event Date 03/26/2024

Event Type  Injury  

Event Description

Revision surgery: infection.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number: 1644408-2023-00244; 509-01-432, 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, 32MM +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: 19169666
• MDR Text Key: 340898500
• Report Number: 1644408-2024-00564
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144650
• UDI-Public: 00888912144650
• 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: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 509-01-432
• Device Lot Number: 389P1142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2021
• 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: 864C6098.
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male