MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3D KNEETM INS, 10L 14MM, VE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	341-14-710
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to pain and instability.
Additional Manufacturer Narrative
See d4expiration date, d9, g4, h3, h4 and h11.Complaint has been evaluated and is similar to: 1644408-2021-01133; 341-12-705, s807 - pain/s814 - stability, poor joint, revision surgery if additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.Note: the item associated with this investigation was returned on (b)(4) to djo surgical - austin for examination.The insert shows some wear, pitting, nicks, and damaged/broken tabs (most likely from being extracted).The base shows the part/lot number are illegible from wear.A cmm inspection could not be attempted due to the damaged tabs.The size verification inspection that could be completed was found to be acceptable.Size verification: 2.917 +/- 015 actual 2.909 (acceptable),.721 +/-.025 actual.719 (acceptable).

• Brand Name: EMPOWR 3D KNEETM INS, 10L 14MM, 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: 19001210
• Report Number: 1644408-2024-00355
• Device Sequence Number: 8501339
• Product Code: FZX
• UDI-Device Identifier: 00888912167468
• UDI-Public: 00888912167468
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/15/2024

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 Expiration Date: 04/14/2025
• Device Catalogue Number: 341-14-710
• Device Lot Number: 134T1033
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 200 KG