MAUDE Adverse Event Report: EXACTECH, INC. NOVATION GXL LNR, NEUTRAL, 28MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-28-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.(d10) concomitant devices: 180-01-52 - nv crown cup clstr hole 52mm group 2: 2272690 120-65-25 - bone screw 6.5mm dia x 25mm long: 2428251 142-28-00 - cocr fem head 28mm +0 offset 12/14: 2526330 160-00-18 - pf stem tapered plasma sz 18: 2167088 if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Approximately 8 year(s), 1 month(s) and 25 day(s) post-operative of a right tha, it was reported via clinical study that the patient experienced polyethylene wear.Right polyethylene wear with eccentric placement of the head on the acetabular liner on x-ray.The patient underwent a revision surgery with the reported removal of the acetabulum liner and femoral head.Additionally, the patient was revised to a competitor¿s devices.The outcome of this event is considered resolved and the clinical report indicates that it is definitely related to the device(s) and possibly related to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.
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 component, and investigation clinical codes.

• Brand Name: NOVATION GXL LNR, NEUTRAL, 28MM ID, GROUP 2 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20824768
• Report Number: 1038671-2024-04583
• Device Sequence Number: 15632539
• Product Code: JDI
• UDI-Device Identifier: 10885862022073
• UDI-Public: 10885862022073
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 04/04/2014
• Device Catalogue Number: 130-28-52
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 03/13/2025
• Date Device Manufactured: 04/06/2010
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: White