MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 8 18MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-818
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Unspecified Infection (1930); Pain (1994); Osteolysis (2377); No Code Available (3191)
Date of Event	10/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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 tibial loosening.Loosening occurred at the cement/implant interface.Cement manufactured by depuy.Doi: unknown; dor: (b)(6) 2016 (unknown knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: 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.

• Brand Name: ATTUNE PS FB INSRT SZ 8 18MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9402702
• Report Number: 1818910-2019-119633
• Device Sequence Number: 13586789
• Product Code: JWH
• UDI-Device Identifier: 10603295050421
• UDI-Public: 10603295050421
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2016

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: 06/30/2018
• Device Model Number: 1516-40-818
• Device Catalogue Number: 151640818
• Device Lot Number: 393403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 07/27/2020
• 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: 59 YR