MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3D KNEETM FEMUR, NP, 4R; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	241-02-104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to original tkr done by dr.(b)(6) diagnosed patellar tracking issue needs to be addressed by a revision tkr due to femoral component mal rotation and revision of patellar resection cut.Dr.Removed the femoral component, tibial insert and patella component.He corrected the femoral rotation and implanted a revision femoral component and stem extesion.He corrected the patella resction with a new cut and replaced the patella.He used a vvc insert which provided the best stability.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
See d4 expiration date, d10, h4 and h11.The reason for this revision surgery, the agent reported "(original tkr done by doctor.Doctor diagnosed patellar tracking issue needs to be addressed by a revision tkr due to femoral component mal rotation and revision of patellar resection cut.Doctor removed the femoral component, tibial insert and patella component.He corrected the femoral rotation and implanted a revision femoral component and stem extesion.He corrected the patella resection with a new cut and replaced the patella.He used a vvc insert which provided the best stability)".The previous surgery and the surgery detailed in this event occurred 10 months apart.This evaluation is limited in scope as the items associated with this investigation were not returned to djo surgical - austin for review.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.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.There was a nonconformance associated with the concomitant part #130-03-729, domed tri-peg patella, 29x8mm, e-plus which documents that out of 40 parts lot 2 part were rejected.1 part was scrapped and rejected due to wrong fixture and another part was scraped and rejected due to scratches on face of part.All other items in the lot were met with fit, form 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.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to mal rotation of femoral component and patellar tracking issue.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 poor bone density, inadequate soft tissue support, patient activities or trauma.

• Brand Name: EMPOWR 3D KNEETM FEMUR, NP, 4R
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19368051
• Report Number: 1644408-2024-00710
• Device Sequence Number: 7689027
• Product Code: FZX
• UDI-Device Identifier: 00888912166713
• UDI-Public: 00888912166713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 07/17/2024

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: 241-02-104
• Device Lot Number: 948R1294
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2023
• 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: 130-03-729 LOT: 154N1769; 342-10-704 LOT: 074T1113; 342-10-704 LOT: 074T1113
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female