MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM

Catalog Number	508-32-104
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery due to a fracture in the central screw.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2023-00338; 508-32-104, s801 - device cracked/broke, revision surgery, surgical - quality complaints.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758-5445 ; 5128346313
• MDR Report Key: 20909293
• Report Number: 1644408-2024-01879
• Device Sequence Number: 7825428
• Product Code: PHX
• UDI-Device Identifier: 00888912024754
• UDI-Public: 00888912024754
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 508-32-104
• Device Lot Number: 866C3020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 506-00-007 LOT 812C1123A.; 506-00-007 LOT: 812C1123A.; 506-03-126 LOT 834C2021.; 506-03-126 LOT: 834C2021.; 506-03-126 LOT: 834C2021.; 506-03-130 LOT 835C1964.; 506-03-130 LOT: 835C1964.; 506-03-130 LOT: 835C1964.; 508-00-000 LOT: 848C2216.; 508-01-032 LOT 859C1192.; 508-01-032 LOT: 859C1192.; 508-32-101 LOT 862C3784.; 508-32-101 LOT: 862C3784.; 508-32-104 LOT 866C3020.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male