MAUDE Adverse Event Report: ENCORE MEDICAL L.P BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 508-32-104

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

Patient Problems Limb Fracture (4518); Implant Pain (4561)

Event Date 11/23/2023

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2019-00140; 508-32-204, 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 and fracture.

• Brand Name: BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM
• 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: 18388491
• MDR Text Key: 331292625
• Report Number: 1644408-2023-01864
• Device Sequence Number: 1
• Product Code: PHX
• 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: 12/21/2023

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: 508-32-104
• Device Lot Number: 866C3042
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• 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: 506-03-126 LOT: 834C1952; 506-03-126 LOT: 834C2011; 508-32-103 LOT: 864C5075; 509-02-032 LOT: 951W2031; 533-08-108 LOT: 926W1714
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female