MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL LT SZ 4 CEM; KNEE FEMORAL

Model Number	1504-40-104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); No Code Available (3191)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: attune crs femoral lt sz 4 cem ()150440104) (h51957).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
Clinical adverse event received for deep venous thrombosis.Event is not serious and is considered moderate.Event is definitely not related to device and there is a remote possibility it is related to procedure.Date of implantation: (b)(6) 2018.Date of event (onset): unknown ((b)(6) 2019) (left knee).Treatment: injected medication and oral medication.

• Brand Name: ATTUNE CRS FEMORAL LT SZ 4 CEM
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9811478
• Report Number: 1818910-2020-07305
• Device Sequence Number: 610519
• Product Code: JWH
• UDI-Device Identifier: 10603295042174
• UDI-Public: 10603295042174
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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 Model Number: 1504-40-104
• Device Catalogue Number: 150440104
• Device Lot Number: H51957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CEMENTED STEM 14X50MM (151214050) (HC7715); ATTUNE FB TIB BASE SZ 4 CEM (150600004) (8859091); ATTUNE MEDIAL DOME PAT 35MM (151820035) (8827560); ATTUNE PS FB INSRT SZ 4 6MM (151640406) (HX9472); COMPETITOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 74