MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL LAT LNR G2 36MM; HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEME

Model Number	HIP-IMPLANT
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, patient had a revision for an unknown reason.Patient was revised to a cc inlay vitamin e, lippe, ø 32, gr.2 (cat# 142-32-62 / serial# (b)(6)).No further information at this time.
Additional Manufacturer Narrative
H2: there is no specific device information provided.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information/reason not reported.These devices are used for treatment not diagnosis.Correction: h6.
Event or Problem Description
It was reported that this patient was revised due to repeated dislocations subsequently to premature inlay wear captured in report number 1038671-2023-02272.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.H3 - the cause of the patient¿s dislocation and subsequent revision reported cannot be conclusively determined; however, it may be due to soft tissue tension, implant positioning, and/or implant selection.However, the failure could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.Dislocation is a known risk, as outlined in the ifu.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, h4, h6.Mdr section codes updated/corrected: b.The cause of the patient¿s dislocation and subsequent revision reported in cannot be conclusively determined; however, it may be due to soft tissue tension, implant positioning, and/or implant selection.However, the failure could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.Dislocation is a known risk, as outlined in the ifu.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: NV EHXL LAT LNR G2 36MM
• Common Device Name: HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEME
• 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 soza
• MDR Report Key: 18395302
• Report Number: 1038671-2023-03057
• Device Sequence Number: 15631011
• Product Code: OQI
• UDI-Device Identifier: 10885862537829
• UDI-Public: 10885862537829
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2024
• Device Model Number: HIP-IMPLANT
• Device Catalogue Number: 146-36-52
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 04/17/2024; 01/30/2025; 06/13/2025; 12/16/2025
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 06/26/2024; 02/13/2025; 07/07/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown