MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; RSP MONOBLOCK SOCKET INSERT, 40MM +4MM, SEMICONSTRAINED, HXE-PLUS

Model Number	509-01-440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number cc- (b)(4) _1644408-2022-00756; 509-01-440, 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
All implants explanted and antibiotic spacer implanted to treat infection.

• Brand Name: DJO SURGICAL
• Common Device Name: RSP MONOBLOCK SOCKET INSERT, 40MM +4MM, SEMICONSTRAINED, HXE-PLUS
• 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: 25461493
• Report Number: 1644408-2026-01143
• Device Sequence Number: 10410623
• Product Code: PHX
• UDI-Device Identifier: 00888912144674
• UDI-Public: 00888912144674
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/10/2026

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 Model Number: 509-01-440
• Device Lot Number: 391P1167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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 832C2610; 506-03-118 832C2618; 506-03-126 834C2658; 506-03-126 834C2659; 506-03-130 835C2598; 508-40-107 4479A1154; 508-80-000 5011A1049; 508-80-040 5029A1031; 510-08-000 142G1662; 530-14-108 415T1647
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male