MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL 10° LNR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 148-36-52

Device Problem Loss of Osseointegration (2408)

Patient Problems Joint Dislocation (2374); Osteolysis (2377)

Event Date 10/18/2023

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a first right hip revision on (b)(6) 2022 and then approximately 1 year later he experienced a second right hip revision surgery on (b)(6) 2023.Revision operative report of (b)(6) 2023- preoperative diagnosis- unstable right hip.Revision of right acetabular component and femoral head exchange and conversion to dual-mobility bearing.Components used: competitor's tritanium multi-hole acetabular shell, size 54 mm outer diameter, size e, with two acetabular cancellous screws, measuring 6.5 x 25 mm and 30 mm, with mdm liner, size 42 mm inner diameter, size e with an mdm x3 dual-mobility insert, size 42 mm outer diameter and 28 mm inner diameter with an exactech, cobalt, chrome femoral head, size 28 mm/+10 offset with a 12/14 taper and montage bone graft filler, size 5 ml.Operative findings: there was found to be a clean wound with clear, synovial joint fluid.There was chronic pulloff of the posterior capsule from posterior capsular repair.There were well-fixed, acetabular and femoral components.There was evidence of posterior instability with the hip inflexion and internal rotation.There was found to be a 5-ml osteolytic contained defect within the superior acetabular dome.This was filled with montage bone graft filler.A revision cup and dual-mobility components were utilized.This provided excellent stability with intraoperative range of motion.There was no noted infection.After placement of implants, the hip was reduced one final time and again found to have good leg lengths and excellent stability.The patient was awakened and transferred to recovery in stable condition.There were no complications.There is no mention of device malfunction or wear in the operative report.There is no other information available.

Manufacturer Narrative

Exactech vitamin e 10-degree lateralized novation xle face-changing liner, group 2, size 36 mm inner diameter and an option adapter +7 mm with a 12/14 taper and an alteon cancellous acetabular screw, measuring 6.5 x 35 mm.These devices are used for treatment not diagnosis.There is no other information available.Pending investigation.

Manufacturer Narrative

H10.Additional information- d4 all and d10.D10.6143067, 148-36-52 - nv ehxl 10â° lnr g2 36mm 7042510, 170-50-07 - biolox delta adapter 16/18-12/14; +7mm 5273104, 180-65-35 - alteon 6.5mm screw, 35mm.

• Brand Name: NV EHXL 10° LNR
• Type of Device: 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: 19209696
• MDR Text Key: 341357535
• Report Number: 1038671-2024-01010
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862537904
• UDI-Public: 10885862537904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 148-36-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 04/29/2024; 04/30/2024
• Supplement Dates FDA Received: 04/29/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 111 KG