MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Joint Laxity (4526)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief, on or about (b)(6) 2018, surgeon removed the failed novation implant from patient and replaced it with another novation hip system.The novation system implanted into patient on (b)(6) 2018 included: novation crown cup connexion gxl +5mm lateralized liner, cocr femoral head, the novation crown cup connexion gxl +5mm lateralized liner implanted into patient on (b)(6) 2018, is subject to an fda class 2 recall and posted on the fda's website on september 9, 2022.On or about (b)(6) 2022, patient underwent surgery to remove the novation where surgeon found that the novation caused osteolysis, the liner to be loose because of poly wear, multiple osteolytic defects that required bone grafting.On or about (b)(6) 2022, surgeon removed the failed novation implant from patient and replaced it with another hip device.
Additional Manufacturer Narrative
Concomitant medical products: cocr fem head 36mm +0 offset 12/14, (catalog# 142-36-00 / serial#: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The most likely cause for the revision reported due to prosthesis wear 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.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d8, e4: remove erroneous entry, g1, g2, h6: clinical code, medical device problem code, component code, type of investigation, and investigation findings.The most likely cause for the revision reported due to prosthesis wear 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.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.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 the patients surgeon removed the failed novation implant from patient and replaced it with another novation hip system.The novation system implanted into patient.The, patient underwent revision surgery to remove the novation implant.The surgeon reported osteolysis and the liner to be loose because of poly wear, multiple osteolytic defects that required bone grafting the surgeon removed the failed novation implant from patient and replaced it with another hip device.No further information is available.

• Brand Name: NV GXL LNR, +5LAT, 36MM G3-56/58MM 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15877677
• Report Number: 1038671-2022-01511
• Device Sequence Number: 5362301
• Product Code: JDI
• UDI-Device Identifier: 10885862024336
• UDI-Public: 10885862024336
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2026

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: 09/10/2018
• Device Model Number: NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
• Device Catalogue Number: 136-36-53
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 03/28/2024; 02/20/2026
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 04/22/2024; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2013
• 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-1729-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male