MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G2 36MM; SEE H10

Model Number	NV EHXL NTRL LNR G2 36MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 73 year old male patient, who was initially implanted in (b)(6) 2017, and had a revision on (b)(6) 2022, underwent a 2nd revision procedure on an unknown date.Reason for the revision not reported.Recalled poly indicated, which was not confirmed.There were no device breakages or surgical delays reported.The patient was last known to be in stable condition following the event.No device returns anticipated.The hospital kept the devices.No device images or patient x-rays provided.No further information.On (b)(6) 2022 revision reported under 1038671-2023-00083.
Additional Manufacturer Narrative
D2b: hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be due to inclusion of the polyethylene in the packaging recall, wear, osteolysis, loosening, infection, fracture, instability/dislocation, leg length discrepancy, and/or patient related factors.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV EHXL NTRL LNR G2 36MM
• Common Device Name: SEE H10
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17611264
• Report Number: 1038671-2023-02035
• Device Sequence Number: 12603770
• Product Code: OQI
• UDI-Device Identifier: 10885862537317
• UDI-Public: 10885862537317
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 08/21/2025

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: 08/12/2025
• Device Model Number: NV EHXL NTRL LNR G2 36MM
• Device Catalogue Number: 140-36-52
• 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: 07/29/2023
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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 Age: 74 YR
• Patient Sex: Male