MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 7 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650712
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	01/01/2018
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
Patient had i&d wash out of her believed infected left total knee on (b)(6) 2017 where her insert was exchanged.This day she presented with a draining painful left total knee.The surgeon felt best treatment for this was to remove the components and placement of antibiotic spacers.No lot numbers were available they did not transfer over with the new scheduling system.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS RP INSRT SZ 7 12MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7330686
• Report Number: 1818910-2018-54876
• Device Sequence Number: 16179323
• Product Code: NJL
• UDI-Device Identifier: 10603295052753
• UDI-Public: 10603295052753
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2018

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 Catalogue Number: 151650712
• Device Lot Number: 8576356
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2018
• Supplement Date Received by Manufacturer: 03/15/2018; 05/04/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 03/21/2018; 05/07/2018
• 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