MAUDE Adverse Event Report: Exactech, Inc. NV GXL LNR, LIPPED, 28MM ID, GROUP 1 CUPS; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	132-28-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Granuloma (1876); Pain (1994); Osteolysis (2377)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 8 years after implantation of a left total hip prosthesis, the patient developed groin discomfort that progressed to pain.Radiographic imaging and bone scan findings did not indicate loosening of the prosthetic components.However, a large granulomatous lesion was identified in the region of implant wear and was associated with suspected polyethylene wear.The patient underwent revision surgery.During the procedure, the granuloma was excised, and the bearing surface components were replaced.The metal implant components were reported to be well-fixed and well-integrated with the surrounding bone.Areas of osteolysis were reconstructed using allograft bone graft material.No further information is available.

• Brand Name: NV GXL LNR, LIPPED, 28MM ID, GROUP 1 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 ct; gainesville, FL 32653 ; +1(352)377-1140
• MDR Report Key: 50670175
• Report Number: 1038671-2026-01141
• Device Sequence Number: 21139198
• Product Code: JDI
• UDI-Device Identifier: 10885862023155
• UDI-Public: 10885862023155
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 03/14/2021
• Device Catalogue Number: 132-28-51
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 03/15/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown