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

Catalog Number	146-36-52
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
As reported, approximately 6 months and 2 days post the patient's first revision surgery, where the inlay was exchanged, the patient presented again due to subluxations.The patient was revised to a specially approved inlay.Patient's first revision reported under 1038671-2024-01747.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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.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 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20925646
• Report Number: 1038671-2024-04818
• Device Sequence Number: 5293701
• 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: 2024
• 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
• Report Date (Section B): 02/24/2025

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 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: 11/26/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• 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; Hospitalization
• Patient Sex: Male