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

Catalog Number	142-36-62
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent an exactech hip prosthesis implant in 2020.Due to premature inlay wear and the company's recall, the revision took place on (b)(6)2024 with the inlay being changed to a specially approved inlay.Due to subluxations and complaints, another change took place on (b)(6) 2024.The patient was presented to our emergency room again on (b)(6) 2024 with local signs of infection from the follow-up treatment.Emergency diagnostics revealed a high suspicion of an early infection, so that another revision was carried out.The suspicion of infection was confirmed and an attempt was made to preserve the prosthesis by changing the inlay and the head, extensive debridement, jet lavage with granudacyn and taking samples for microbiological testing.A staph.Aureus infection was detected here.Intravenous antibiotics were administered for 14 days in accordance with the antibiogram, which were then orally administered for a further 10 weeks.The patient was able to be discharged back to the ahb facility.(b)(6) 2024 revision reported under mdr# 1038671-2024-01747.(b)(6) 2024 revision reported under mdr# 1038671-2024-04818.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d4 - catalog #, serial #, udi, exp date.H4 - mfg date.The following sections were corrected: d6a.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.A review of the sterile certificates and/or the final endotoxins report was performed.All lots were accepted to the requirements.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical 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 ALIP LNR G2 36MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21210003
• Report Number: 1038671-2025-00340
• Device Sequence Number: 8071733
• Product Code: LZO
• UDI-Device Identifier: 10885862537638
• UDI-Public: 10885862537638
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2025

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: 142-36-62
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 01/20/2025; 04/04/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 02/05/2025; 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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
• Patient Sex: Male