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

Catalog Number	132-36-52
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Based  on the available information, the patient meets the following risk criteria for early prosthesis wear and/or osteolysis: implanted with a lateralized liner, combination of largest available femoral head and/or thinnest available acetabular liner was used, and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the reported revision due to prosthesis wear and osteolysis may have been a combination of risk factors such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: NOVATION HIP
• Common Device Name: 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: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19111601
• Report Number: 1038671-2024-00842
• Device Sequence Number: 7099564
• Product Code: JDI
• UDI-Device Identifier: 10885862207036
• UDI-Public: 10885862207036
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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 Expiration Date: 11/06/2022
• Device Catalogue Number: 132-36-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1732-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 79 KG