MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 60 yo female patient, initial implant of the left knee on (b)(6) 2016, was revised due to early gxl poly wear on (b)(6) 2022, approximately 5 years 9 months post the initial implant date.They were revised to novation xle poly.Patient was last known to be in stable condition following the event.The devices are available for return.
Additional Manufacturer Narrative
Concomitants: 4339937 188-00-05 - wedge plasma s/o sz 5, 4492908 142-32-00 - cocr fem head 32mm +0 offset 12/14, 4552056 180-01-50 - nv crown cup clstr hole 50mm group 1.(b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear as specified; 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 revision reported due to prosthesis wear is a combination of the risk factors specified.
Event or Problem Description
It was reported that a femalepatient, initial implant of the left knee and then was revised due to early gxl poly wear, approximately 5 years 9 months post the initial implant date.They were revised to novation xle poly.Patient was last known to be in stable condition following the event.The devices are available for return.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were added/corrected: b1, b2, b5, d1, g1, h6: clinical code, component code, investigation findings, investigation conclusions.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 LNR, +5LAT, 32MM G1-48/50MM 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: geoff gannon ; 3523771140
• MDR Report Key: 15546265
• Report Number: 1038671-2022-01249
• Device Sequence Number: 5635577
• Product Code: JDI
• UDI-Device Identifier: 10885862024275
• UDI-Public: 10885862024275
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 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): 02/24/2026

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: 02/20/2017
• Device Model Number: NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS
• Device Catalogue Number: 136-32-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 07/28/2023; 02/18/2026
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 08/08/2023; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2012
• 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-1729-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female