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

Catalog Number 509-00-036

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

Patient Problem Implant Pain (4561)

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2018-01022; 509-00-032, s807 - pain, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

Event Description

Revision surgery - due to pain.

• Brand Name: RSP STANDARD 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: 19056502
• MDR Text Key: 339550992
• Report Number: 1644408-2024-00419
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144544
• UDI-Public: 00888912144544
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 509-00-036
• Device Lot Number: 378P1289
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2020
• 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: 506-03-118 LOT: 832C1477; 506-03-126 LOT: 834C1716; 506-03-126 LOT: 834C1718; 508-36-101 LOT: 869C2959
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male