MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR 3D KNEETM INS, 5R 10MM, VE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	342-10-705
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to infection.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2023-00477; (b)(6), s808 - infection, revision surgery if additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: EMPOWR 3D KNEETM INS, 5R 10MM, 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: 18297827
• Report Number: 1644408-2023-01814
• Device Sequence Number: 12627485
• Product Code: FZX
• UDI-Device Identifier: 00888912167321
• UDI-Public: 00888912167321
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 12/08/2023

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: 06/11/2026
• Device Catalogue Number: 342-10-705
• Device Lot Number: 075T1125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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: 130-03-732 LOT: 155N1983; 241-02-105 LOT: 949R1342; 351-04-105 LOT: 032T1012
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female