MAUDE Adverse Event Report: ENCORE MEDICAL, L.P DJO SURGICAL; RSP HUMERAL SOCKET INSERT, 36MM +4MM, STANDARD HXE-PLUS

Catalog Number	509-00-436
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2021-01488; 509-00-436 and 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
It was reported that the patient required revision surgery due to an infection.

• Brand Name: DJO SURGICAL
• Common Device Name: RSP HUMERAL SOCKET INSERT, 36MM +4MM, STANDARD HXE-PLUS
• 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: 23059683
• Report Number: 1644408-2025-01347
• Device Sequence Number: 13217153
• Product Code: KWS
• UDI-Device Identifier: 00888912144582
• UDI-Public: 00888912144582
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 09/15/2025

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: 509-00-436
• Device Lot Number: 386P1325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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: 506-03-118 LOT CODE 832C2338; 506-03-118 LOT CODE 832C2349; 506-03-122 LOT CODE 833C2142; 506-03-130 LOT CODE 835C2319; 508-32-204 LOT CODE 769P3345; 508-36-101 LOT CODE 869C4358; 530-12-108 LOT CODE 412T1846
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male