MAUDE Adverse Event Report: EXACTECH, INC. NOVATION GXL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a 56 yo male patient, who had a right tha on (b)(6) 2017, presented back to the surgeon with complaints about their tha.Upon examination, the patient had an exactech primary total hip in.The patient presented with pain, stiffness, and dissatisfaction with their right total hip.The novation gxl liner was recalled, and the cup component showed a lesion or bone defect behind the cup.The patient had revision tha surgery on (b)(6) 2023, approximately 5 years 9 months post the initial procedure.They underwent an acetabular poly liner swap and a femoral head swap including bone graft into the acetabulum.There was a 15-30 mins surgical delay during the procedure as it took extra time to apply bone void filler into the acetabulum.The event was not related to any breakage of device.The patient left the or stable.The device was returned for analysis.
Additional Manufacturer Narrative
D10: concomitants: 4693332, 186-01-56 - integrip cc, cluster 56mm,g3; 4803179, 188-00-08 - wedge plasma s/o sz 8; 4820426, 101-05-30 - 3.2mm drill bit30mm 1pk; 4838100, 180-65-30 - alteon 6.5mm screw, 30mm; 4861123, 170-36-00 - biolox delta femoral head 36mm od, +0mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The revision reported was likely the result of increased prosthesis wear due to edge loading/impingement and patient-related issues which led to polyethylene wear and osteolysis.Additionally, edge-loading is a risk factor for early wear of the gxl liner.
Additional Manufacturer Narrative
These devices are used for treatment not diagnosis.Pending investigation.
Event or Problem Description
Revision operative report of (b)(6) 2023- postoperative diagnosis: filed right total hip arthroplasty secondary to polyethylene wear and osteolysis due to defective polyethylene acetabular liner.Procedure: there is a physiological amount of joint fluid in the hip, no evidence of infection.The femoral head was removed and was grossly undamaged.The stem was not loose.There were no gross abnormalities of the liner.The metal shell demonstrates no abnormalities.The locking mechanism is intact.Osteolytic lesions-moderate to large defect superiorly.Devices were trialed and then implanted.Dressings were applied.The patient tolerated the procedure well.There were no known intraoperative complications.The patient was transferred to recovery room in stable condition.No additional information is available.

• Brand Name: NOVATION GXL
• 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: 16781681
• Report Number: 1038671-2023-00777
• Device Sequence Number: 6987394
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/02/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
• Device Catalogue Number: 132-36-53
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/01/2023; 04/02/2024; 05/12/2026
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 10/03/2023; 05/06/2024; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• 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-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male