MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL ALIP LNR G4 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number NV EHXL ALIP LNR G4 36MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Joint Dislocation (2374)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: biolox delta option femoral head 36mm od (cat# 170-36-50 / serial# (b)(4).Biolox delta adapter 16/18-12/14; +0mm (cat# 170-50-00 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately seven months post revision of right side tha, patient presented with a dislocation.Surgeon performed a revision with goal of removing the novation cup and converting to a link dual mobility.Unfortunately bone was severely damaged with osteolysis and upon impacting the new cup the medial wall was perforated.After attempting multiple times to get a stable cup using screws, surgeon consulted his partners and it was decided to close the patient without an acetabular component, order a ct scan, and plan for a more involved reconstruction with plating and augmentation next week.Patient last known to be in stable condition.The devices are not available for evaluation due to hospital policy.510k: k173583.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, approximately seven months post revision of right-side tha, patient presented with a dislocation.Surgeon performed a revision with goal of removing the novation cup and converting to a link dual mobility.Unfortunately, bone was severely damaged with osteolysis and upon impacting the new cup the medial wall was perforated.After attempting multiple times to get a stable cup using screws, surgeon consulted his partners and it was decided to close the patient without an acetabular component, order a ct scan, and plan for a more involved reconstruction with plating and augmentation next week.Patient last known to be in stable condition.The devices are not available for evaluation due to hospital policy.Additional information received indicates that patient's cultures were positive, so the patients stem was removed today with antibiotic spacer implanted surgeon.Left in stable condition.Infection is found to be one of the most serious complications after total knee arthroplasty.Currently the incidence of prosthetic knee infection is 1-3%, antibiotic prophylaxis is the most effective method of prosthetic joint infection.Knee joints are susceptible to infection due to the following: scant muscle coverage, pre-existing conditions of the patient (immunosuppression, rheumatoid arthritis, diabetes mellitus, and obesity) it was also found that increased rates of infection were seen in septic arthritis increased the risk of infection if prosthesis were implanted in that joint and prior surgical interventions to the primary prosthetic implant.From: martinez-pastor, j.M.-b.-v.(2019).Acute infection in total knee arthroplasty: diagnosis and treatment.13.The open orthopaedics journal.

Manufacturer Narrative

H3: his male patient underwent tha of the right hip with an exactech novation hip system and a novation gxl 36mm lipped acetabular liner on (b)(6) 2011, by dr.(b)(6).As reported in previous case (mfr# 1038671-2022-00238), approximately 10 year and 4 months post implantation, the patient reported hip pain and an mri showed fluid collection in the pelvis from the liner wear.The patient was revised for poly wear by dr.(b)(6) on (b)(6) 2022 (captured under (b)(4)).The gxl liner was removed and was exchanged for a 36mm ehxl alip lnr.The patient was reported to be in stable condition following the revision surgery.The investigation in this case determined that ¿the revision reported in was likely the result of edge loading and being implanted for over 10 years, which led to polyethylene wear and pain.As reported in this complaint, approximately 7 months later, the patient presented with a hip dislocation.Dr (b)(6) decided to perform a revision on (b)(6) 2022 with the goal of removing the novation cup and converting to a link dual mobility unfortunately, the bone was severely damaged with osteolysis from the previously reported poly wear related to the gxl liner and, upon impacting the new cup, the medial wall was perforated.After attempting multiple times to get a stable cup using screws, dr (b)(6) consulted his partners and it was decided to close the patient without an acetabular component, order a ct scan, and plan for a more involved reconstruction with plating and augmentation next week.In (b)(6) 2022, cultures taken during the surgery on (b)(6) 2022 were positive, so dr.(b)(6) removed the patient¿s stem and implanted an antibiotic spacer.The patient left the or in stable condition.The rep later responded in (b)(6) 2023, that he did not have the specific culture result information.Infection and deep infection are known risks in any total joint surgery.The sterile certificates were reviewed for each device reported, each of the sterile certificates indicate ¿the product meets customer specifications; zero nonconformities occurred during each irradiation run¿.This device was used for treatment, not diagnosis.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 of the xle acetabular liner.The most likely cause of the reported event appears to be the results of the patient¿s history of poly wear resulting in osteolysis/poor bone quality, which likely contributed to dislocation.The cause of the infection cannot be conclusively determined; however, it is most likely related to patient and surgical factors.

• Brand Name: NV EHXL ALIP LNR G4 36MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15628838
• MDR Text Key: 301975267
• Report Number: 1038671-2022-01324
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862537652
• UDI-Public: 10885862537652
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2023

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 Expiration Date: 08/19/2023
• Device Model Number: NV EHXL ALIP LNR G4 36MM
• Device Catalogue Number: 142-36-64
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 02/22/2023; 04/21/2023
• Supplement Dates FDA Received: 03/13/2023; 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2018
• 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 Sex: Male