MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G4 40MM; HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEME

Catalog Number	140-40-54
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 (6792531) 170-40-50 - biolox delta option femoral head 40mm od.(7281198) 170-50-03 - biolox delta adapter 16/18-12/14; +3.5mm.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of new york.Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.
Additional Manufacturer Narrative
Based on the available information, the patient meets the following risk criteria for early prosthesis wear and/or osteolysis: 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 reported revision due to prosthesis wear and osteolysis may have been a combination of 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).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: NV EHXL NTRL LNR G4 40MM
• 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: 20517977
• Report Number: 1038671-2024-04102
• Device Sequence Number: 8811016
• Product Code: OQI
• UDI-Device Identifier: 10885862537362
• UDI-Public: 10885862537362
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2023
• Device Catalogue Number: 140-40-54
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 06/03/2025
• Date Device Manufactured: 05/15/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 63 YR
• Patient Sex: Unknown