MAUDE Adverse Event Report: Encore Medical L.P DJO SURGICAL; EMPOWR 3D KNEETM INS, 11L 10MM, VE

Catalog Number	341-10-711
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to unknown revision reason / poly swap.
Additional Manufacturer Narrative
The agent reported "(poly swap)".The previous surgery and the surgery detailed in this event occurred 2 years and 11 months apart.Item number: 341-10-711 item description: empowr 3d kneetm ins, 11l 10mm, ve lot number: 071t1007 part revision: a product type: knee manufacture date: 03/04/16 expiration date: 02/27/21.This evaluation is limited in scope as the items associated with this investigation were 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 the reported devices were 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 poly swap.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 also contribute to an event that are outside the control of djo surgical such as patient bone deterioration, poor bone density, inadequate soft tissue support, patient activities or trauma.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) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.First, there was a ncmr#42657 associated with the concomitant part #353-01-111, djo empowr kneetm, press fit bp, 11l, which documents that out of 15 parts lot, all parts were rejected due to dimension out of tolerance.Later the rejected parts were accepted to use as is after proper justification.Second, there was a nonconformance associated with the same part which documents that out of 15 parts lot, 1 part was rejected and scrapped due to dimension out of tolerance.All other items in the lot were met with the design, fit and function requirements.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Complaint history: customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.

• Brand Name: DJO SURGICAL
• Common Device Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE
• 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: 50334414
• Report Number: 1644408-2026-01727
• Device Sequence Number: 5751206
• Product Code: JWH
• UDI-Device Identifier: 00888912166881
• UDI-Public: 00888912166881
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 08/19/2026

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: 02/27/2021
• Device Catalogue Number: 341-10-711
• Device Lot Number: 071T1007
• 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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2016
• 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: 243-01-111 Lot. 280W1009; 353-01-111 Lot. 196W1008
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male