MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR FB INSRT SZ 7 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151620708
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/13/2017
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
The implants were removed due to infection, please see reference and lot numbers of implants below, attune femur size 7 right ref: 150400207 lot: 8088260-02.Attune tibia size 6 ref: 150600008 lot: 8331994.Attune fb insert size 8mm x 7 ref: 151620708 lot: 647466.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information indicates the primary operation was in 2016 and revision was on (b)(6) 2018.It is not reasonable to conclude that the device contributed to the patient's infection, 3+ after implantation.
Additional Manufacturer Narrative
Pc(b)(4).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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FB INSRT SZ 7 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7177926
• Report Number: 1818910-2018-50721
• Device Sequence Number: 1066594
• Product Code: JWH
• UDI-Device Identifier: 10603295045915
• UDI-Public: 10603295045915
• Combination Product (Y/N): N
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/14/2017

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: 151620708
• Device Lot Number: 647466
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 01/16/2018; 09/27/2018; 09/27/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 01/19/2018; 09/27/2018; 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1