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

Catalog Number	509-01-036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported, "shoulder instability and potential infection.Male 66yrs" the previous surgery and the surgery detailed in this event occurred 10 months, 17 days apart.Item number: 509-01-036."item description: empowr ps kneetm tibial insert, size 5, 11mm." lot number: 382p1216.Part revision: c.Product type: shoulder.Manufacture date: 22-oct-2024.Expiration date: 18-oct-2029.This evaluation is limited in scope as the item(s) associated with this investigation was not returned to djo surgical - austin for examination.The surgery was completed as intended and without incident and no delay.If additional information regarding the reported event and information regarding cultures identified in the infection, the severity of the infection is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate that the reported device(s) was defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.Root cause: the root cause of this complaint was a revision surgery performed due to instability and potential infection.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event or inhibited the patient's immune system.There are multiple factors that may contribute to an event that are outside of the control of enovis surgical.Containment: inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.Device history records review: a review of the device history record(s) shows that the reported component(s) used in the previous surgery met design and manufacturing requirements at the time of release for use.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Complaint history: customer complaint history of the reported device(s) showed no present trends or ongoing issues that need review.
Event or Problem Description
Revision surgery - due to infection and instability.

• Brand Name: DJO SURGICAL
• Common Device Name: RSP SEMICONSTRAINED 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 ; 5128346313
• MDR Report Key: 24678168
• Report Number: 1644408-2026-00528
• Device Sequence Number: 10149382
• Product Code: PHX
• UDI-Device Identifier: 00888912144629
• UDI-Public: 00888912144629
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/23/2026

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: 509-01-036
• Device Lot Number: 382P1216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• 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: 508-36-107 LOT: 4478A1065
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male