MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G3 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	140-36-53
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial tha on an unknown date.The patient was revised on (b)(6) 2023.No further information has been provided at this time.
Additional Manufacturer Narrative
H3: pending investigation.
Additional Manufacturer Narrative
According to the information provided, the patient had a hip replacement in 2018.The patient was revised due to prosthesis wear.A novation xle neutral liner (140-36-53, sn (b)(6)) was implanted at that time.Approximately one month later, the patient was revised again due to infection.The liner and femoral head were revised.However, only part information for the liner was provided.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined.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, the patient had an initial tha on an unknown date.The patient was revised due to infection.The liner and femoral head were revised.No further information has been provided at this time.
Event or Problem Description
As reported, the patient had a tha revision.Approximately one month later, the patient was revised again due to infection.The liner and femoral head were revised.No further information has been provided at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d6a.The following sections were corrected: b5.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined.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 G3 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18127855
• Report Number: 1038671-2023-02762
• Device Sequence Number: 6394179
• Product Code: JDI
• UDI-Device Identifier: 10885862537324
• UDI-Public: 10885862537324
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/26/2025

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: 07/12/2025
• Device Catalogue Number: 140-36-53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 10/30/2024; 10/30/2024; 03/26/2025
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 11/12/2024; 03/21/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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; Hospitalization
• Patient Sex: Male