MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 130-36-54

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

H10.D10.Concomitants: 4148874, 164-01-14 - element-stem, collarless w/ha, std offset, sz 14.4653649, 170-36-00 - biolox delta femoral head 36mm od, +0mm.4617767, 170-36-03 - biolox delta femoral head 36mm od, +3.5mm.4488386, 186-01-60 - integrip cc, cluster 60mm, g4.Presumed left hip -4415175, 130-36-54 - nv gxl linr, ntrl, 36mm id, group 4 cups, serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.H3.Investigation results: the nv gxl linr, ntrl, 36mm id, group 4 cups device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and the reason for the planned revision are not reported.There is insufficient information to determine the relationship of the devices to the patient's condition at this time.When more information is received it will be evaluated and additional actions taken as appropriate.These devices are used for treatment not diagnosis.H6.Health effect - impact code is for pending surgical revision.There is no other information available.

Event Description

It was reported via legal documentation that a patient had a total right hip arthroplasty on (b)(6) 2016, with a planned revision, as of (b)(6) 2024 the revision date and surgical information have not been received.Scheduled date for revision was reported to be (b)(6) 2023.There is no other information provided/available.

• Brand Name: NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
• Type of Device: 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 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19089286
• MDR Text Key: 339985726
• Report Number: 1038671-2024-00808
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862022240
• UDI-Public: 10885862022240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

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 Expiration Date: 05/17/2021
• Device Catalogue Number: 130-36-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 04/11/2024
• Date Device Manufactured: 05/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1729-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention