MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 4 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Joint Disorder (2373); No Code Available (3191)
Date of Event	09/19/2018
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
Left knee revision due to loosening of the tibial component, and instability.Doi: (b)(6) 2016; dor: (b)(6) 2018 (rt 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.H6 patient code: no code available (3191) used to capture the joint instability, surgical intervention and medical device removal.

• Brand Name: ATTUNE CR FB INSRT SZ 4 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9452812
• Report Number: 1818910-2019-122479
• Device Sequence Number: 14219663
• Product Code: OIY
• UDI-Device Identifier: 10603295045557
• UDI-Public: 10603295045557
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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 Model Number: 1516-20-408
• Device Catalogue Number: 151620408
• Device Lot Number: 599138
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 09/17/2020
• 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 RT SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; COMPETITOR BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR