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

Model Number	508-32-104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation: the agent reported, "infection weakened baseplate fixation to glenoid.Glenoid components removed.Allograft filled defects.New glenoid components implanted." the previous surgery and the surgery detailed in this event occurred 7 years, 3 months, 4 days apart.Item number: 508-32-104 item description: baseplate, glenoid ha-coat, rsp, 6.5mm x 30mm lot number: 866c2454 part revision: h product type: shoulder manufacture date: 19-dec-2018 expiration date:13-dec-2023.This evaluation is limited in scope as limited information was provided to enovis surgical - austin for examination.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information is submitted at a future date, this investigation will be re-evaluated.There were no findings during this evaluation that indicate that the reported device(s) was the source or had a direct connection with the patient's infection.Root cause: the root cause of this complaint was a revision surgery due to the loss of glenoid baseplate fixation due to infection, requiring removal of the components, allograft reconstruction, and implantation of new glenoid components.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside of the control of enovis surgical.Containment: inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.Device history records review: a review of the device history record(s) shows that the reported component(s) used in the previous surgery met design and manufacturing requirements at the time of release for use.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Complaint history: customer complaint history of the reported device(s) showed no present trends or ongoing issues that need review.
Event or Problem Description
Infection weakened baseplate fixation to glenoid.Glenoid components removed.Allograft filled defects.New glenoid components implanted.

• Brand Name: DJO SURGICAL
• Common Device Name: BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd.; austin, TX 78758 ; 8003219549
• MDR Report Key: 24670300
• Report Number: 1644408-2026-00456
• Device Sequence Number: 14731946
• Product Code: PHX
• UDI-Device Identifier: 00888912024754
• UDI-Public: 00888912024754
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/19/2026

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: 02/22/2024
• Device Model Number: 508-32-104
• Device Lot Number: 866C2454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2018
• 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 831C1549; 506-03-114 831C1576; 506-03-122 833C1447; 506-03-126 834C1478; 508-32-103 864C3160
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female