MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM NAR POR CR LT SZ 4; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Catalog Number 150401124

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 01/01/2023

Event Type  Injury  

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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b3: date of event is an unknown date in 2023.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from depuy synthes japan reports an event as follows: it was reported that on (b)(6) 2023, an implant surgery was performed via tka for oa in both knees.On (b)(6) 2023, the patient came to the hospital due to swelling in the left knee.The reason for the infection and the event date are unknown.The surgery for left knee cleaning is scheduled for (b)(6) 2023.No further information is available.

• Brand Name: ATTUNE FEM NAR POR CR LT SZ 4
• Type of Device: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17397164
• MDR Text Key: 319836219
• Report Number: 1818910-2023-15235
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 10603295041412
• UDI-Public: 10603295041412
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 150401124
• Device Lot Number: 3931074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ATTUNE CR RP INSRT SZ4 7MM; ATTUNE RP TIB BASE SZ 4 CEM
• Patient Outcome(s): Required Intervention