MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE FEM POR PS LT SZ 8; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Catalog Number	150411108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Patient had cementless total knee arthroplasty on (b)(6) 2018.Post op day one developed positive cultures for infection.Patient was brought back to or for one stage explant of knee components & revision total knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 FEM POR PS LT SZ 8
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8094673
• Report Number: 1818910-2018-76157
• Device Sequence Number: 11482825
• Product Code: JWH
• UDI-Device Identifier: 10603295041931
• UDI-Public: 10603295041931
• Combination Product (Y/N): N
• PMA/510(K) Number: K140881
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2018

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: 150411108
• Device Lot Number: 8901745
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 11/21/2018; 12/06/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 11/30/2018; 12/21/2018
• 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: 62 YR
• Patient Weight: 100