MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Insufficient Information (4580)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 164-01-09 - element-stem, collarless w/ha, std offset, sz 9: (b)(6).180-11-52 - nv crown cup clsr hl w/ha 52 group 2: (b)(6).01-032-03-3694 - universal cup, head, delta, 36mm, -4: 20020526/047.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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, a patient underwent an initial total hip arthroplasty on the right side.Subsequently, the patient was diagnosed with early wear of the prosthetic polyethylene with particulate disease, was admitted to the hospital, and needs surgical intervention to prevent injury or permanent disability.No further information provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6.
Event or Problem Description
Additional information received indicates the patient was revised.

• Brand Name: NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 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 66th ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24603442
• Report Number: 1038671-2026-00259
• Device Sequence Number: 21209086
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2026

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: 08/03/2024
• Device Catalogue Number: 130-36-52
• Was Device Available for Evaluation?: No
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 05/26/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 03/16/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown