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
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Osteolysis (2377); Insufficient Information (4580)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d7a.The following sections were corrected: b1 b2 g2 h6.The most likely cause for the reported revision due to prosthesis wear and osteolysis is a combination of the risk factors such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19089286
• Report Number: 1038671-2024-00808
• Device Sequence Number: 7071573
• Product Code: LZO
• UDI-Device Identifier: 10885862022240
• UDI-Public: 10885862022240
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown