MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151620710
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Not Applicable (3189)
Date of Event	05/02/2018
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
First stage knee revision the surgeon (b)(6) hospital (b)(6) 2018; primary (b)(6) 2017.First stage revision (b)(6) 2018: seven months post primary surgery, patient developed heat and swelling in right knee.Knee aspirated (b)(6) 2018.Nil bacterial growth noted.Patient had reports of "continuous aching" in right knee.Nil signs of implant subsidence, or loosening.First stage revision with antibiotic spacer.Nil further details known.Male patient id: (b)(6); d.O.B: (b)(6).
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, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FB INSRT SZ 7 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7556879
• Report Number: 1818910-2018-61021
• Device Sequence Number: 1698668
• Product Code: JWH
• UDI-Device Identifier: 10603295045922
• UDI-Public: 10603295045922
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 05/02/2018

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: 151620710
• Device Lot Number: 512686
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 08/06/2018
• 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: 68 YR
• Patient Weight: 99