MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3D KNEETM INS, 8R 12MM, VE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	342-12-708
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to tibia did not ingrow - we had to remove the femur to get the tibia component out.
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
The reason for this revision surgery, the agent reported, "(tibia did not in grow.We had to remove the femur to get the tibia component out)".The previous surgery and the surgery detailed in this event occurred, 8 months and 3 weeks apart.This evaluation is limited in scope, as the items associated with this investigation were not returned to (b)(6) 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.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.There was an ncmr#: (b)(4).Associated with the concomitant part #: 244-02-108, empowr porous femur with ha nano, 8r.Which document, that out of 9 parts lot, all parts were rejected, due to op- 540 didn't remeasure the parts for any size verification, after the came from ha coating vendor.Later, the rejected parts were reworked and accepted after proper justification.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.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 tibial in-growth.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 (b)(6) such as poor bone density, inadequate soft tissue support, patient activities or trauma.

• Brand Name: EMPOWR 3D KNEETM INS, 8R 12MM, VE
• 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: 19580657
• Report Number: 1644408-2024-00940
• Device Sequence Number: 17989937
• Product Code: FZX
• UDI-Device Identifier: 00888912167451
• UDI-Public: 00888912167451
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/19/2024

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: 342-12-708
• Device Lot Number: 122T1124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2023
• 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: 110-03-735 LOT: 1596A1032; 244-02-108 LOT: 3259A1016; 353-04-108 LOT: 223W1055
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male