MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EXPRT KNEE; INSERT, REVISION EXPRT, SZ C X 19.5MM, E-PLUS

Model Number	315-0C-719
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - surgeon wanted a thicker tibia insert to address instability.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: EXPRT KNEE
• Common Device Name: INSERT, REVISION EXPRT, SZ C X 19.5MM, E-PLUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 12759133
• Report Number: 1644408-2021-01110
• Device Sequence Number: 16923918
• Product Code: JWH
• UDI-Device Identifier: 00888912114110
• UDI-Public: (01)00888912114110
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K140830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 11/02/2021

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 Expiration Date: 06/01/2025
• Device Model Number: 315-0C-719
• Device Catalogue Number: 315-0C-719
• Device Lot Number: 014R1027A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 88 KG