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

Model Number	1516-30-710
Medical Device Problem Codes	Unstable (1667); Unintended Movement (3026); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/10/2018
Type of Reportable Event	Serious Injury
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.(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
Litigation received.Revision due to pain and instability.
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 CR RP 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: 8006409
• Report Number: 1818910-2018-73554
• Device Sequence Number: 13835740
• Product Code: NJL
• UDI-Device Identifier: 10603295048022
• UDI-Public: 10603295048022
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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 Expiration Date: 12/31/2017
• Device Model Number: 1516-30-710
• Device Catalogue Number: 151630710
• Device Lot Number: 3546572
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 08/06/2020
• 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: 55 YR