MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; FEMUR, REVISION EXPRT KNEE, SZ C LT

Catalog Number	215-0C-008
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to loosening.
Additional Manufacturer Narrative
The agent reported "dr.Believed the femoral component was loose.Revised femur for stiffness, lack of rom, ambulatory revised to empower femoral component and vvc+ insert" the previous surgery and the surgery detailed in this event occurred 5.7 yrs.Apart.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.A review of the device history record(s) show that the reported component(s) used in the previous surgery, when released for use, met design and manufacturing requirements.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.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are needing a review.This is the 1st complaint against the part/lot number combination.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.The root cause of this complaint was a revision surgery due to femoral component was loose.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.

• Brand Name: DJO SURGICAL
• Common Device Name: FEMUR, REVISION EXPRT KNEE, SZ C LT
• 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: 24112157
• Report Number: 1644408-2026-00111
• Device Sequence Number: 18475237
• Product Code: JWH
• UDI-Device Identifier: 00888912110853
• UDI-Public: 00888912110853
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K140830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• 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): 01/19/2026

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: 10/21/2025
• Device Catalogue Number: 215-0C-008
• Device Lot Number: 966P1031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2019
• 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: 215-0C-005 LOT: 986U1017.; 215-0C-005 LOT: 986U1017.; 215-12-040 LOT: 527U1004.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male