MAUDE Adverse Event Report: Encore Medical L.P DJO SURGICAL; RSP HUMERAL SOCKET INSERT, 40MM +4MM, STANDARD HXe-plus

Catalog Number	509-00-440
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to instability.
Additional Manufacturer Narrative
The agent reported, revised to treat instability.Age 69 gender female.Complaint has been evaluated and is similar to report number 1644408-2023-00283; 509-00-436, 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 HUMERAL SOCKET INSERT, 40MM +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: 50766716
• Report Number: 1644408-2026-01854
• Device Sequence Number: 9668426
• Product Code: KWS
• UDI-Device Identifier: 00888912144599
• UDI-Public: 00888912144599
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/14/2026

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: 509-00-440
• Device Lot Number: 387P1131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2024
• 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: 508-40-101 Lot. 875C1491A; 510-08-000 Lot. 142G1617
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female