MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR RP INSRT SZ 9 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151630905
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	01/01/2016
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
Patient was revised due to continued pain.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Device history lot: null.Device history batch: null.Device history review: null.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 RP INSRT SZ 9 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7620997
• Report Number: 1818910-2018-62742
• Device Sequence Number: 13927686
• Product Code: NJL
• UDI-Device Identifier: 10603295048220
• UDI-Public: 10603295048220
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 151630905
• Device Lot Number: 8094716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention