MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; RSP MONOBLOCK SOCKET INSERT, 36MM +4MM, SEMICONSTRAINED, HXE-PLUS

Catalog Number	509-01-436
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported, "scapular notching.Male 78." the previous surgery and the surgery detailed in this event occurred 4 years, 11 months, 18 days apart.Item number: 509-01-436.Item description: altivate anatomic, neutral humeral head, 50x20.Lot#: 390p1056.Part revision: a.Product type: shoulder.Manufacture date: 30-mar-2019.Expiration date: 18-mar-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 a revision surgery due to scapular notching.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 a nonconforming material report (ncmr# b)(4)) associated with 510-08-000, which documented that out of 50 parts in the lot, 28 parts were identified for rework due to blast not being uniform and scratches on the blasted surface.The affected parts were evaluated and determined to be suitable for rework with no new unacceptable risk to performance or safety.Following rework, the units were accepted after proper justification.A total of 22 parts were accepted as-is and 28 parts were reworked, with no parts scrapped.All other items in the lot 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 scapular notching, unknown cause.

• Brand Name: DJO SURGICAL
• Common Device Name: RSP MONOBLOCK SOCKET INSERT, 36MM +4MM, SEMICONSTRAINED, 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: 25225290
• Report Number: 1644408-2026-00942
• Device Sequence Number: 15903076
• Product Code: PHX
• UDI-Device Identifier: 00888912144667
• UDI-Public: 00888912144667
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 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): 05/19/2026

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: 03/18/2024
• Device Catalogue Number: 509-01-436
• Device Lot Number: 390P1056
• 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: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2019
• 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: 510-08-000 LOT: 142G1361
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown