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

Catalog Number	400-03-363
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 1644408-2021-01147; 400-03-362 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 hip was infected.The surgeon removed all implants and replaced it with new ones.

• 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: 23059686
• Report Number: 1644408-2025-01348
• Device Sequence Number: 9987725
• Product Code: LZO
• UDI-Device Identifier: 00888912076142
• UDI-Public: 00888912076142
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K082844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• 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: 400-03-363
• Device Lot Number: 868B1544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 04/24/2023
• 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: 425-97-009 LOT CODE 174R1434.; 940-00-015 LOT CODE 144Z1026.; 940-00-015 LOT CODE 144Z1087.; 940-00-020 LOT CODE 145Z1093.; 940-00-020 LOT CODE 145Z1094.; 940-00-025 LOT CODE 146Z1242.; 940-00-035 LOT CODE 148Z1164.; 940-03-54G LOT CODE 816Z1014.; 942-01-36G LOT CODE 623Z1081.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female