MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, 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)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an original exactech primary total hip replacement on (b)(6) 2017.The 77 y/o female patient returned to surgeon's office complaining about their primary hip pain and dissatisfaction.Upon examination and imaging the poly showed wear and is involved in the recall.The patient underwent revision left tha on (b)(6) 2023 where the patient underwent a full total hip revision using competitor's devices.The patient left the operating room (or) stable.There was no breakage of device.There was a 30-45 minutes surgery delay due to patient had to be under anesthesia and in surgery longer than anticipated when going to a full revision.Images and x-rays received.The devices are not available for evaluation due to the implants were sent to the lab and legal at the hospital.
Additional Manufacturer Narrative
Section d10: concomitant products: biolox delta femoral 40mm od, +0mm (cat#: 170-40-00 / serial#: (b)(6).Alteon 6.5mm screw, 40mm (cat#: 180-65-40 / serial#: (b)(6).Integrip cc, cluster 56mm,g3 (cat#: 186-01-56 / serial#: (b)(6).Alt ha s noclr ext sz 8 (cat#: 190-21-08 / serial#: (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The patient/gxl acetabular liner involved was reportedly revised due to prosthesis wear approximately 5 years and 10 months after the index surgery.The revised components were not returned for evaluation and no radiographs were provided.However, images were provided.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used and implanted with a component having a shelf age of greater than 2 years.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors specified in the hhe.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
Based on the available information, the patient meets the following risk criteria for early prosthesis wear and/or osteolysis: implanted with a lateralized liner, combination of largest available femoral head and/or thinnest available acetabular liner was used, and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the reported revision due to prosthesis wear and osteolysis may have been a combination of 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.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17362036
• Report Number: 1038671-2023-01719
• Device Sequence Number: 6079723
• Product Code: JWH
• UDI-Device Identifier: 10885862207043
• UDI-Public: 10885862207043
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2023
• 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): 02/04/2025

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: 01/27/2018
• Device Model Number: NV GXL LINER LIPPED 40MM ID, GROUP 3 CUPS
• Device Catalogue Number: 132-40-53
• 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: 07/02/2023
• Supplement Date Received by Manufacturer: 03/08/2024; 02/04/2025
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 05/09/2024; 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.2MM DRILL BIT30MM 1PK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 78 KG