MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	142-40-63
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 142-40-63 - nv ehxl alip lnr g3 40mm (b)(6).170-40-50 - biolox delta option femoral head 40mm od (b)(6).170-50-00 - biolox delta adapter 16/18-12/14; +0mm (b)(6).Cs-10cc - intersep calcium sulfate (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 70 yo male patient, who had a left tha, underwent a revision procedure approximately 1 year 1 month post the prior procedure.The patient had a prior surgery to swap out a recalled hip poly liner in (b)(6) 2025, and the patient presented back with signs of a localized infection around the hip incision and deeper.Fluid was pulled from the hip and tested.The patient was scheduled for an i&d implant exchange.The patient underwent surgery to wash out the infected hip joint and receive implant exchanges.Antibiotic beads were placed inside the hip joint as well.There were no surgical delays or device breakages during the procedure.No x-rays were provided.The explanted devices are not available for return.Device image was provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d4 serial #, h4 mfg date.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: NOVATION
• 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; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25017730
• Report Number: 1038671-2026-00505
• Device Sequence Number: 9713842
• Product Code: LZO
• UDI-Device Identifier: 10885862537676
• UDI-Public: 10885862537676
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 04/30/2026

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 Catalogue Number: 142-40-63
• 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: 04/05/2026
• Supplement Date Received by Manufacturer: 04/05/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male