MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR FB INSERT SZ 4 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189); No Code Available (3191)
Date of Event	03/29/2017
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
Received medical records on 06/26/2018.Medical records reviewed for mdr reportability.Right attune total knee revised to address pain and instability.Revising surgeon noted that the pcl was incompetent, on a cr non-stabilized knee replacement.Attune femur, tibial tray, and tibial insert components were revised to competitor products; the attune patella component was retained.Competitor cement was used during the primary surgery.Doi: (b)(6) 2016; dor: (b)(6) 2017; (right knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H6 patient code: no code available (3191) was used to capture joint instability and surgical intervention.

• Brand Name: ATTUNE CR FB INSERT SZ 4 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7901392
• Report Number: 1818910-2018-70142
• Device Sequence Number: 165194
• Product Code: JWH
• UDI-Device Identifier: 10603295045540
• UDI-Public: 10603295045540
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2018

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: 09/30/2017
• Device Model Number: 1516-20-407
• Device Catalogue Number: 151620407
• Device Lot Number: 296729
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 08/05/2020
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 12/04/2018; 08/06/2020
• 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: 53 YR