MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 40MM ID, GROUP 5 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINER LIPPED 40MM ID, GROUP 5 CUPS
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Tissue Breakdown (2681); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products:¿ biolox delta option femoral head 40mm od (cat# 170-40-50 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the 66 y/o male patient was brought back for right hip pain.The bone scan suggested a loose cup.The femur was dislocated and the femoral head removed.The stem was checked and found to be well fixed.Attention turned to the cup.The liner was removed with the help of a bone screw.The cup was checked and found to be well fixed.It had already been revised one time before on (b)(6) 2016 elsewhere.There is no information from that revision only that it was revised to a novation multihole cup with 4 screws and the +7 head.The patient received a g5 xle novation extended liner and a new cobalt chrome head.There was no breakage of a device or surgical delay,prolongation.X-rays received.The devices are not available for evaluation due to patient requested implants.
Additional Manufacturer Narrative
As reported, the 66 y/o male patient was brought back for right hip pain.The bone scan suggested a loose cup.The femur was dislocated, and the femoral head removed.The stem was checked and found to be well fixed.Attention turned to the cup.The liner was removed with the help of a bone screw.The cup was checked and found to be well fixed.It had already been revised one time before on (b)(6) 2016 elsewhere.There is no information from that revision only that it was revised to a novation multi-hole cup with 4 screws and the +7 head.The patient received a g5 xle novation extended liner and a new cobalt chrome head.There was no breakage of a device or surgical delay/prolongation.X-rays received.The devices are not available for evaluation due to patient requested implants.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.
Event or Problem Description
Reported via legal notification.The patient has filed a short-form complaint.The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action were required "to undergo revision surgeries due to severe, pain, swelling, and instability" due to "wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries." because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of a polyethylene device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely cause for the revision reported due to early 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, it cannot be confirmed on the provided radiographs and the devices were not available for evaluation.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 LINER LIPPED 40MM ID, GROUP 5 CUPS
• Common Device Name: 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: 16448768
• Report Number: 1038671-2023-00256
• Device Sequence Number: 5875876
• Product Code: JDI
• UDI-Device Identifier: 10885862207067
• UDI-Public: 10885862207067
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/06/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2017
• Device Model Number: NV GXL LINER LIPPED 40MM ID, GROUP 5 CUPS
• Device Catalogue Number: 132-40-55
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 06/21/2023; 05/20/2024; 03/05/2025
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 07/18/2023; 12/30/2024; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2012
• 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-1732-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male