MAUDE Adverse Event Report: Exactech, Inc. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu

Catalog Number	130-32-51
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hip replacement.Subsequently, the patient experienced persistent hip pain, inflammation, and limited mobility.Additional symptoms included noises, clicking sensations, and a feeling of instability while walking.Radiographic evaluation reportedly confirmed loosening and osteolysis.Due to these findings, the treating orthopedic surgeon recommended revision surgery to remove and replace the affected implant components.The outcome of the revision procedure, if performed, was not reported.No further information is available.

• Brand Name: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu
• 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: 50820557
• Report Number: 1038671-2026-01200
• Device Sequence Number: 10157827
• Product Code: MEH
• UDI-Device Identifier: 10885862207074
• UDI-Public: 10885862207074
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 05/09/2026
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 05/10/2021
• 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 Age: 58 YR
• Patient Sex: Unknown