MAUDE Adverse Event Report: ENCORE MEDICAL L.P GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 508-36-101

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 11/22/2023

Event Type  malfunction  

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

Instrument failure - 30 minute delay in surgery.

Manufacturer Narrative

Complaint has been evaluated and is similar to previous report number 1644408-2023-00929; 508-32-103, s801 - device cracked/broke, primary surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL
• 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: 18388653
• MDR Text Key: 331492733
• Report Number: 1644408-2023-01837
• 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,Followup
• Report Date: 01/26/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 508-36-101
• Device Lot Number: 869C4048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male