MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CRS RP INSRT SZ 4 8MM; KNEE TIBIAL INSERT

Catalog Number	151710408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	12/03/2018
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
The primary surgery was performed via tka (date of primary surgery was unknown).It was reported that the surgeon recognized infection after the revision surgery (date of revision surgery was unknown) thus, the 2nd revision surgery was performed by washing out the debris and replacing the liner (p/n: 151710408).The surgery was completed without any problems.No further information was provided by the hospital.
Additional Manufacturer Narrative
Product complaint # (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 CRS RP INSRT SZ 4 8MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8203146
• Report Number: 1818910-2018-79392
• Device Sequence Number: 218250
• Product Code: NJL
• UDI-Device Identifier: 10603295055808
• UDI-Public: 10603295055808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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: 151710408
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 01/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention