MAUDE Adverse Event Report: ENCORE MEDICAL L.P GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 508-32-103

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

Patient Problem Joint Dislocation (2374)

Event Date 02/26/2024

Event Type  Injury  

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2022-01619; 508-32-103, s803 - dislocation, 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 dislocation.

• Brand Name: GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM
• 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: 18984540
• MDR Text Key: 338658143
• Report Number: 1644408-2024-00347
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024747
• UDI-Public: 00888912024747
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 508-32-103
• Device Lot Number: 864C6253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2023
• 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: 509-03-432 LOT: 954W1173
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female