MAUDE Adverse Event Report: EXACTECH, INC. NOVATION HIP; NV GXL LINER LIPPED 36MM ID GROUP 2

Catalog Number 132-36-52

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): 4918620 - 170-36-00 - biolox delta femoral head 36mm od, +0mm 4911485 - 186-01-52 - integrip cc, cluster 52mm, g2 4916214 - 190-21-05 - alt ha s noclr ext sz 5.

Event Description

It was reported that a 73 yo female patient, who had an initial total hip replacement on (b)(6) 2018, underwent a revision procedure on (b)(6) 2024, approximately 6 years 3 months post the initial procedure.The patient returned to the surgeon¿s office with a recalled hip liner.The patient was scheduled for a revision of their total hip.The patient had revision surgery and underwent an acetabular poly liner swap and femoral head swap.There were no device breakages or surgical delays during the procedure.No x-rays were provided.The patient was last known to be in stable condition following the event.The explanted products are not available for return.They were sent to the lab and legal at the hospital.No device images were provided.No further information.

• Brand Name: NOVATION HIP
• Type of Device: NV GXL LINER LIPPED 36MM ID GROUP 2
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19111601
• MDR Text Key: 340223390
• Report Number: 1038671-2024-00842
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862207036
• UDI-Public: 10885862207036
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/15/2024

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 Expiration Date: 11/06/2022
• Device Catalogue Number: 132-36-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1732-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 79 KG