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

Catalog Number	509-00-036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery, patient presented approximately four weeks post op for reverse total shoulder with symptoms of early possible infection.Surgeon opted to revise after irrigation and debridement.Glenosphere and insert were removed and replaced.
Additional Manufacturer Narrative
The agent reported a revision surgery due to patient presented approximately four weeks post op for reverse total shoulder with symptoms of early possible infection.Surgeon opted to revise after irrigation and debridement.Glenosphere and insert were removed and replaced.Complaint has been evaluated and is similar to report number 1644408-2023-00928; 509-00-436, s808 - infection, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, 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: 25211554
• Report Number: 1644408-2026-00947
• Device Sequence Number: 10355012
• Product Code: PHX
• UDI-Device Identifier: 00888912144544
• UDI-Public: 00888912144544
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/18/2026

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 Catalogue Number: 509-00-036
• Device Lot Number: 378P1978
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2026
• 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: 508-36-101 LOT: 869C5205.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male