MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL LT SZ 3 CEM; KNEE FEMORAL

Model Number	1504-40-103
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Clinical adverse event received for deep venous thrombosis.Event is not serious and is considered moderate.Event is definitely not related to device and is probably related to procedure.Date of implantation: (b)(6) 2021.Date of event (onset): (b)(6) 2021.(left knee).Treatment: oral medication (unspecified).
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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CRS FEMORAL LT SZ 3 CEM
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12167542
• Report Number: 1818910-2021-15185
• Device Sequence Number: 14378772
• Product Code: JWH
• UDI-Device Identifier: 10603295042167
• UDI-Public: 10603295042167
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 1504-40-103
• Device Catalogue Number: 150440103
• Device Lot Number: J8464C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/09/2021
• 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: ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CRS FB INSRT SZ 3 14MM; ATTUNE CRS FEMORAL LT SZ 3 CEM; ATTUNE DIST FEM AUG SZ 3 8MM; ATTUNE DIST FEM AUG SZ 3 8MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE POS FEM AUG SZ 3 8MM; ATUN PRESSFIT STR STEM12X110MM; ATUNE PRESSFIT STR STEM12X60MM; DEPUY CMW 1G 40G; ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CRS FB INSRT SZ 3 14MM; ATTUNE CRS FEMORAL LT SZ 3 CEM; ATTUNE DIST FEM AUG SZ 3 8MM; ATTUNE DIST FEM AUG SZ 3 8MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE POS FEM AUG SZ 3 8MM; ATUN PRESSFIT STR STEM12X110MM; ATUNE PRESSFIT STR STEM12X60MM; DEPUY CMW 1G 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 100