MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 8 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-806
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); No Code Available (3191)
Date of Event	05/27/2020
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.(b)(4).
Event or Problem Description
Clinical notification received for revision of left knee to address instability, pain, and edema.Date of implantation: (b)(6) 2019, date of revision: (b)(6) 2020, (left knee).Treatment: tibial insert was revised.
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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATTUNE CR FB INSRT SZ 8 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10301600
• Report Number: 1818910-2020-16347
• Device Sequence Number: 515598
• Product Code: JWH
• UDI-Device Identifier: 10603295046011
• UDI-Public: 10603295046011
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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 Model Number: 1516-20-806
• Device Catalogue Number: 151620806
• Device Lot Number: J30J84
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FEM LT SZ 8 CEM; ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE MEDIAL DOME PAT 41MM
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 134