MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-705

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

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient presented to dr.With a fever and painful left knee.Index surgery on patient¿s left knee was performed by dr.On (b)(6) 2021 at (b)(6) hospital.Dr.Elected to irrigate and debrid the left knee and exchange the index sz 7 x 5mm attune ps poly.Upon exposure to the joint dr.Removed the well fixed poly insert with an osteotome and then proceeded to check the remaining components for loosening and found all remaining components to be well fixed.Dr.Then proceeded to implement his treatment for a potentially infected total knee.Dr.Then implanted a new sz 7 x 5 mm attune ps poly insert and then proceeded to close the wound.Nothing broke during surgery.There was no loosening.Dr.Believes the components performed as expected.There were no delays to the procedure.

• Brand Name: ATTUNE PS FB INSRT SZ 7 5MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16006160
• MDR Text Key: 305724081
• Report Number: 1818910-2022-25739
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1516-40-705
• Device Catalogue Number: 151640705
• Device Lot Number: JF5098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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
• Patient Outcome(s): Required Intervention