MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; RSP STANDARD HUMERAL SOCKET INSERT, 44MM, HXE-PLUS

Catalog Number	509-00-044
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported, "poly disassociated.Male 77" the previous surgery and the surgery detailed in this event occurred 5 years, 9 months, 19 days apart.Item number: 509-00-044, item description: rsp standard humeral socket insert, 44mm, hxe-plus, lot#: 380p1009a, part revision: b, product type: shoulder, manufacture date: 23-sep-2019, expiration date: 13-sep-2024.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.If additional information regarding the reported event 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 poly disassociation, which required revision surgery.No information was submitted with the complaint regarding the patient's pre-existing conditions or any patient activities that may have contributed to the event.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 records (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was ncmr-51956 associated with the main part (509-00-044), which documented that out of 20 parts in the lot, 2 parts were identified as wrong size.The affected parts underwent standard batching rework and were accepted after proper justification.Additionally, ncmr-52092 was associated with the concomitant part (508-44-101), which documented that out of 10 parts in the lot, 2 parts were identified with surface scratches on the polished area exceeding 0.250.The affected parts were reworked with dimensional inspection and subsequently accepted.All other items in the lots met fit, form, and function requirements.The devices were verified to have undergone an acceptable sterilization process and were within their 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 poly disassociated.

• Brand Name: DJO SURGICAL
• Common Device Name: RSP STANDARD HUMERAL SOCKET INSERT, 44MM, 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: 25156539
• Report Number: 1644408-2026-00881
• Device Sequence Number: 21218069
• Product Code: KWS
• UDI-Device Identifier: 00888912144568
• UDI-Public: 00888912144568
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/12/2026

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 Expiration Date: 09/13/2024
• Device Catalogue Number: 509-00-044
• Device Lot Number: 380P1009A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2019
• 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: 506-03-114 LOT: 831C1776.; 506-03-114 LOT: 831C1776.; 506-03-122 LOT: 833C1548.; 506-03-134 LOT: 836C1317.; 508-32-204 LOT: 769P1812.; 508-44-101 LOT: 877C1083.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male