MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; INSERT, CONSTRAINED, P.S., SIZE8 22MM CM

Catalog Number	370-22-508
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to infection and pain.
Additional Manufacturer Narrative
The agent reported: "infection/pain causing removal of revision knee.Replaced with a hinge knee.Male 64".The previous surgery and the surgery detailed in this event occurred 7 months, 12 days apart.Item number: 370-22-508, "item description: insert, constrained, p.S., size8 22mm cm", lot#: 408b1003, part revision: f, product type: knee, manufacture date:07-jun-2024, expiration date: 29-may-2029.This evaluation is limited in scope as limited information was provided to enovis surgical - austin for examination.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information is submitted at a future date, this investigation will be re-evaluated.There were no findings during this evaluation that indicate that the reported device(s) was the source or had a direct connection with the patient's infection.Root cause: the root cause of this complaint was a revision surgery due to infection and pain.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 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, CONSTRAINED, P.S., SIZE8 22MM CM
• 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: 25628151
• Report Number: 1644408-2026-01270
• Device Sequence Number: 14922094
• Product Code: JWH
• UDI-Device Identifier: 00888912116947
• UDI-Public: 00888912116947
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K933539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/25/2026

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: 370-22-508
• Device Lot Number: 408B1003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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: 200-05-008 LOT: 692A1048A; 200-05-008 LOT: 692A1048A; 205-01-008 LOT: 751A1033; 210-10-008 LOT: 782A1914A; 210-10-108 LOT: 789A1911A; 220-10-020 LOT: 864A1030A; 320-15-016 LOT: 159B1051A; 321-01-108 LOT: 168B1911A; 322-05-108 LOT: 201B1038
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male