MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 3 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-306
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); No Code Available (3191)
Date of Event	12/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The primary surgery was performed on (b)(6) 2018 by implanting the femoral component, the tibial tray, the tibial insert for the patient¿s left knee joint.After the surgery, the patient sprained her ankle joint on (b)(6) 2020 (this event was reported as (b)(4)).It was reported that the patient had chest pain on (b)(6) 2019, and she was advised exam by primary care doctor.Then, she underwent cag under hospitalization on (b)(6) 2020 at (b)(6) hospital, and she was admitted into the hospital from (b)(6) 2020.She has no symptom now and is in treatment with medication.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.H10 additional narrative:.

• Brand Name: ATTUNE CR RP INSRT SZ 3 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10393288
• Report Number: 1818910-2020-17910
• Device Sequence Number: 13954311
• Product Code: NJL
• UDI-Device Identifier: 10603295047513
• UDI-Public: 10603295047513
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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: 09/30/2022
• Device Model Number: 1516-30-306
• Device Catalogue Number: 151630306
• Device Lot Number: 8648562
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FEM POR CR LT SZ 3; ATTUNE RP TIB BASE SZ 3 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 73