MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FB INSRT SZ 10 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151641010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Date of Event	04/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Patient was revised to address infection.Poly exchange was performed.Doi: (b)(6) 2018, dor: (b)(6) 2018; right knee.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint # :(b)(4).Investigation summary : no device associated with this report was received for examination.

• Brand Name: ATTUNE PS FB INSRT SZ 10 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7502613
• Report Number: 1818910-2018-59315
• Device Sequence Number: 1108735
• Product Code: JWH
• UDI-Device Identifier: 10603295050667
• UDI-Public: 10603295050667
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2018

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: 03/31/2019
• Device Catalogue Number: 151641010
• Device Lot Number: 515330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 08/21/2018
• 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: 44 YR