MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Impingement (4834)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately five years post initial post left tha, this 71 y/o male patient was in some pain and gxl liner was having problems.Surgeon revised the gxl liner and biolox head.Surgeon re-implant a xle liner lipped 40mm and biolox delta adapter 3.5 with 40mm head.There was no breakage of a device and no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays were received.The device will ne return.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3, g6, h2, h3, h6, h7 and h9 have been updated accordingly.(h3 the patient involved was reportedly revised due to pain and ¿gxlliner having problems¿ approximately 5 years after the index surgery.Wear and edge loading was able to be confirmed from the provided radiographs and explanted device.The returned liner appears to have evidence of impingement.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear, the edge loading of the femoral head on the acetabular liner, and combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely underlying cause for the revision reported is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, d8, h3, h6: clinical code, component code, type of investigation, investigation conclusion.The most likely underlying cause for the revision reported is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.Wear and edge loading was able to be confirmed from the provided radiographs and explanted device.The returned liner appears to have evidence of impingement.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 3 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 jacobon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15178820
• Report Number: 1038671-2022-00893
• Device Sequence Number: 6269552
• Product Code: JDI
• UDI-Device Identifier: 10885862207043
• UDI-Public: 10885862207043
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2025

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: 04/26/2021
• Device Model Number: NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS
• Device Catalogue Number: 132-40-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 08/23/2023; 11/20/2025
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/25/2023; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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-1732-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male