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 Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Agent reported revision surgery due to patient felt discomfort.Complaint has been evaluated and is similar to report number 1644408-2022-00748; 348-16-705, s808 - infection, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.
Event or Problem Description
Revision surgery - due to patient felt discomfort.

• 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
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd.; austin, TX 78758
• MDR Report Key: 25772767
• Report Number: 1644408-2026-01317
• Device Sequence Number: 10453798
• Product Code: PHX
• UDI-Device Identifier: 00888912024754
• UDI-Public: 00888912024754
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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 Expiration Date: 08/01/2025
• Device Catalogue Number: 508-32-104
• Device Lot Number: 866C2670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2019
• 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: 506-03-114 LOT: 831C1714.; 506-03-114 LOT: 831C1726.; 506-03-130 LOT: 835C1589.; 506-03-130 LOT: 835C1591.; 508-36-103 LOT: 871C1259.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female