MAUDE Adverse Event Report: Encore Medical L.P. DJO SURGICAL; INSERT, ONLAY TIBIAL, EPIK, SIZE40X9

Catalog Number	340-40-009
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to pain and instability.
Additional Manufacturer Narrative
The agent reported, "patient presented with instability and pain.Male 58".The previous surgery and the surgery detailed in this event occurred 11 years, 27 days apart.Item number: 340-40-009."item description: insert, onlay tibial, epik, size40x9".Lot#: 328b1011.Part revision: a.Product type: knee.Manufacture date: 23-oct-2014.Expiration date: 28-oct-2019.This evaluation is limited in scope as the item(s) associated with this investigation was not returned to (b)(6) for examination.The surgery was completed as intended.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 revision surgery for instability and pain.There are multiple factors that may contribute to this 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.

• Brand Name: DJO SURGICAL
• Common Device Name: INSERT, ONLAY TIBIAL, EPIK, SIZE40X9
• 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 ; +1(512)834-6313
• MDR Report Key: 50010815
• Report Number: 1644408-2026-01418
• Device Sequence Number: 14913151
• Product Code: HRY
• UDI-Device Identifier: 00888912116022
• UDI-Public: 00888912116022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/23/2026

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 Expiration Date: 10/28/2019
• Device Catalogue Number: 340-40-009
• Device Lot Number: 328B1011
• 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: 07/06/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2014
• 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: 200-01-110 Lot: 679A1003.; 300-01-040 Lot: 068B1008.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male