MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE REVERSE GLENOSPHERE DISTRACTOR

Catalog Number	804-06-343
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - poly swap, unknown reason.
Additional Manufacturer Narrative
See h6 and h11.The agent reported as an instrument failure.This event occurred during surgery, away from the patient.No risk or adverse event was reported by the surgeon.There was no delay in surgery, and the surgery was completed as intended.The instruments were inspected prior to use and acceptable.There was another suitable device available when the event occurred.The reported instrument was not returned to enovis surgical for evaluation.No further evaluation can be made of this event.This customer complaint will be closed.If the device is returned later, the complaint will be updated.Customer complaint history of the reported device(s) showed no present trends or ongoing issues that are needing a review.There are no indications that the instrument has a design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.The revision level or lot number were not reported; therefore this instrument could not be linked to a specific device history record (dhr) or the actual date of manufacture could not be determined with confidence.The root cause of this complaint was an instrument failure, likely due to rough handling or extensive use.This is an event associated with use, not an event associated with product failure, malfunction, or issue.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE GLENOSPHERE DISTRACTOR
• 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: 23589956
• Report Number: 1644408-2025-01696
• Device Sequence Number: 18622930
• Product Code: LXH
• UDI-Device Identifier: 00190446844945
• UDI-Public: 00190446844945
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: A776463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 804-06-343
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown