MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 4 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	06/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Literature article entitled, ¿does circumferential patellar denervation result in decreased knee pain and improved patient-reported outcomes in patients undergoing non-resurfaced, simultaneous bilateral tka?¿ by nicolaas c.Budhiparama md, et al, published by clinical orthopaedics related research (2020), vol.428, pp.2020-2033 was reviewed.The purpose of this study was to evaluate the efficacy of patellar denervation in 78 patients receiving bilateral attune primary tkas without patellar resurfacing between feb 2015 and october 2016.In all bilateral procedures, the patellar denervation via cauterization of the patellar rim was always performed on the right knee.The authors concluded that there was no clinical difference between the cauterized and non-cauterized knees.Depuy components: attune femoral component, tibial tray, and tibial insert.There was no patellar resurfacing and the type of cement used is unknown.Results: 3 reports of deep vein thrombi at 6 months post index tka.The authors note that all were treated successfully, but the intervention that was provided was not specified.Captured in this complaint: 3 bilateral attune tkas for deep vein thrombus (3 right knees and 3 left knees).
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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CR FB INSRT SZ 4 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11186882
• Report Number: 1818910-2021-01355
• Device Sequence Number: 2766022
• Product Code: NJL
• UDI-Device Identifier: 10603295045533
• UDI-Public: 10603295045533
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 12/31/2020
• Device Model Number: 1516-20-406
• Device Catalogue Number: 151620406
• Device Lot Number: 731833
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 03/16/2021
• 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: 70 YR