MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 4 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-204

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

Patient Problems Unspecified Infection (1930); Sepsis (2067); Dizziness (2194)

Event Date 04/02/2023

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.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2022, the primary surgery was performed via tka for oa with the implants in question.The surgery was completed successfully without any surgical delay.On (b)(6) 2023, the patient was rushed to the hospital in the morning due to dizziness, speech disturbance, and decreased level of consciousness because of suspected sepsis due to infection.With vitals back to normal, the patient was transferred to this facility, where a thorough examination was conducted and infection was confirmed.The revision surgery was performed on (b)(6) 2023, to remove all the implants and place the antibiotic cement mold.Also, drains were placed.The surgery was completed successfully without any surgical delay.The infection was caused by pus that had accumulated in the toe.History of diabetes mellitus.No further information is available.

• Brand Name: ATTUNE PS FEM RT SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16752517
• MDR Text Key: 313421746
• Report Number: 1818910-2023-08089
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041757
• UDI-Public: 10603295041757
• 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: 04/17/2023

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 Model Number: 1504-10-204
• Device Catalogue Number: 150410204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2023
• Initial Date FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE CEMENTED STEM 14X30MM; ATTUNE PS RP INSRT SZ5 5MM; ATUN TIB AUG UNIV SZ 5/6 5MM; ATUNE REV RP TIB BASE SZ 5 CEM
• Patient Outcome(s): Required Intervention