MAUDE Adverse Event Report: EXACTECH, INC. NOVATION GXL LNR +5 LAT 40MM ID GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NOVATION GXL LNR +5 LAT 40MM ID GROUP 4 CUPS
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 101-05-20 - 3.2mm drill bit 20mm 1pk 170-40-00 - biolox delta femoral 40mm od, +0mm 180-65-20 - alteon 6.5mm screw, 20mm 186-01-60 - integrip cc, cluster 60mmm g4 190-31-12 - alt ha s clr ext sz 12 additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a male patient, initial left hip implanted on an unknown date, underwent a revision procedure on (b)(6) 2024.The patient had lysis around the cup and stem.The implants were removed and replaced with a competitor¿s devices.X-ray images were provided.There were no device breakages or surgical delays during the procedure.The patient was last known to be stable following the event.No device returns anticipated.The devices were sent to pathology.Device images were provided.No further information.
Additional Manufacturer Narrative
H3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear.A combination of largest available femoral head and/or thinnest available acetabular liner was used and implanted with a lateralized liner.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors specified.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, d6a, h4, h6.Mdr section codes updated/corrected: a, b, c, d, g.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: significant edge loading of the femoral head on the acetabular liner, 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 revision reported due to early prosthesis wear and osteolysis is a combination of the 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).The prosthesis wear was able to be confirmed from the provided radiograph.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NOVATION GXL LNR +5 LAT 40MM ID GROUP 4 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18602295
• Report Number: 1038671-2024-00135
• Device Sequence Number: 9016846
• Product Code: JDI
• UDI-Device Identifier: 10885862220318
• UDI-Public: 10885862220318
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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: 04/02/2022
• Device Model Number: NOVATION GXL LNR +5 LAT 40MM ID GROUP 4 CUPS
• Device Catalogue Number: 136-40-54
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 03/21/2025
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 04/15/2024; 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male