MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	130-32-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please disregard initial report as it was determined that this device was reported in error.
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported by legal notification, approximately 5 years and 3 months post the initial right total hip replacement, the patient was revised due to possible femoral loosening.No further information provided.

• Brand Name: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21127425
• Report Number: 1038671-2025-00198
• Device Sequence Number: 6829778
• Product Code: JWH
• UDI-Device Identifier: 10885862207074
• UDI-Public: 10885862207074
• Combination Product (Y/N): N
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 07/24/2022
• Device Catalogue Number: 130-32-51
• 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: 04/13/2020
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2017
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male