MAUDE Adverse Event Report: ENCORE MEDICAL L. P. 3DKNEE SYSTEM; EMPOWR 3D KNEETM INS, 7R 14MM, VE

Model Number	342-14-707
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/24/2021
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 quad tendon partial rupture.Replaced the insert.

• Brand Name: 3DKNEE SYSTEM
• Common Device Name: EMPOWR 3D KNEETM INS, 7R 14MM, VE
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11704184
• Report Number: 1644408-2021-00336
• Device Sequence Number: 17031608
• Product Code: JWH
• UDI-Device Identifier: 00888912167543
• UDI-Public: (01)00888912167543
• 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 Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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 Model Number: 342-14-707
• Device Catalogue Number: 342-14-707
• Device Lot Number: 141T054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR