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

Catalog Number	151620407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Edema (1820); Pain (1994); Discomfort (2330); No Code Available (3191)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: initial reporter occupation: lawyer.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
Medical records received ad 17 june 2019.On (b)(6) 2014, the patient underwent a right knee manipulation under anesthesia due to pain, discomfort, stiffness, swelling, and arthrofibrosis.No products were revised during the procedure.On (b)(6) 2018, the patient underwent a right knee revision due to stiffness and tibial tray loosening at the cement to implant interface.The patella was not revised.Competitor cement was used during the primary operation.Doi: (b)(6) 2014.Doe: (b)(6) 2014.Dor: (b)(6) 2018.Right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a duplicate report of 1818910-2018-70010.This is being retracted as it is a report duplication.1818910-2018-70010 will be kept for investigational purposes.

• 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: 9268507
• Report Number: 1818910-2019-113726
• Device Sequence Number: 16578112
• Product Code: JWH
• UDI-Device Identifier: 10603295045540
• UDI-Public: 10603295045540
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: No Information
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 151620407
• Device Lot Number: 336454
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/06/2019
• 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: 65 YR