MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G2 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	140-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Implant Pain (4561)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
Mdr report #: mw5146332.It was reported via medwatch by a female patient that they started having hip pain after 3 years.Liner had premature wear and failed causing the pain and a revision surgery 4 years later.Devices will not be returning - patient requested explants.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h3: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear.The reported prosthesis wear could not be confirmed.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.
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 the result of prosthesis wear.The reported prosthesis wear could not be confirmed.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: 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18091630
• Report Number: 1038671-2023-02717
• Device Sequence Number: 12292997
• Product Code: JDI
• UDI-Device Identifier: 10885862537317
• UDI-Public: 10885862537317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2025

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: 05/21/2024
• Device Catalogue Number: 140-36-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 04/25/2025; 05/16/2025
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 05/15/2025; 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2019
• 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
• Patient Sex: Unknown