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

Catalog Number	151620608
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189); No Code Available (3191)
Date of Event	03/28/2018
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 to address pain and instability after a fall.Exchanged for one size thicker insert.Doi: (b)(6) 2016; dor: (b)(6) 2018; right knee.
Additional Manufacturer Narrative
Product complaint # : (b)(4).No device associated with this report was received for examination.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 FB INSRT SZ 6 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7453624
• Report Number: 1818910-2018-58075
• Device Sequence Number: 19072443
• Product Code: JWH
• UDI-Device Identifier: 10603295045793
• UDI-Public: 10603295045793
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: 151620608
• Device Lot Number: 627270
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/28/2018
• 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: 65 YR
• Patient Weight: 97