MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DJO SURGICAL; RSP STANDARD HUMERAL SOCKET INSERT, 40MM, HXE-PLUS

Catalog Number	509-00-040
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unstable (1667)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
The patient presented approximately four (4) years postoperatively from a reverse total shoulder arthroplasty with complaints of instability.The surgeon elected to revise the implant to a larger glenosphere.During the procedure, the existing glenosphere and insert were removed and replaced.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2023-00025, 509-00-032, s814 - stability, poor joint, 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, 40MM, 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: 23399419
• Report Number: 1644408-2025-01587
• Device Sequence Number: 13254287
• Product Code: PHX
• UDI-Device Identifier: 00888912144551
• UDI-Public: 00888912144551
• 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: 2021
• 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,Followup
• Report Date (Section B): 10/27/2025

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: 509-00-040
• Device Lot Number: 379P1103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2021
• 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: 508-40-101 LOT CODE 875C1312
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 91 KG