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

Catalog Number	151630408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling (2091); No Code Available (3191)
Date of Event	01/17/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
The patient underwent an irrigation and debridement on (b)(6) 2015 due to infection and swelling.No products were revised during the procedure.The surgeon decided on (b)(6) 2015 to go back in for another irrigation and debridement with a tibial insert exchange due to the ongoing infection.The patient was also treated with intravenous antibiotics.Doi: (b)(6) 2014.Doe: (b)(6) 2015, irrigation and debridement (no products revised).Dor: (b)(6) 2015, tibial insert exchanged right 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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 4 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 9111558
• Report Number: 1818910-2019-105986
• Device Sequence Number: 3587478
• Product Code: NJL
• UDI-Device Identifier: 10603295047650
• UDI-Public: 10603295047650
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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: 151630408
• Device Lot Number: 7662190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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: 70 YR