MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 16MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650516
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Date of Event	05/23/2018
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
Der states second i&d due to infection.Original dos was (b)(6) 2018, with the first i&d on (b)(6) 2018.The wound looked clean and dry for 10 days after the first i&d but than began draining again thus requiring the second i&d with poly exchange.The joint cultured positive for staph-epi.Doi: (b)(6) 2018; dor: (b)(6) 2018; right knee.
Additional Manufacturer Narrative
Product complaint #:(b)(4).Investigation summary :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 will be filed as appropriate.

• Brand Name: ATTUNE PS RP INSRT SZ 5 16MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7613356
• Report Number: 1818910-2018-62545
• Device Sequence Number: 1397082
• Product Code: NJL
• UDI-Device Identifier: 10603295052494
• UDI-Public: 10603295052494
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/23/2018

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: 151650516
• Device Lot Number: 8640889
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/20/2018
• 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: 81 YR
• Patient Weight: 74