MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-36-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1 year and 1 month post the initial left total hip arthroplasty, the patient was revised due to pain and osteolysis.A competitor acetabular augment with bone grafting cement was used with a new vit e exactech liner and head.There were no issues.The hip was stable.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D10: 170-36-00 - biolox delta femoral head 36mm od, +0mm: (b)(6), 118-41-04 - p-series pf plasma h/o collarless sz 4 12/14: (b)(6), 180-01-56 - nv crown cup clstr hole 56mm group 3: (b)(6), 620-00-02 - platelet rich plasma kit with spray tips: (b)(6), 620-11-02 - accelerate conc.Sys rep by 620-12-02: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: NV GXL LNR, LIPPED, 36MM ID, GROUP 3 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23681236
• Report Number: 1038671-2025-03462
• Device Sequence Number: 9846457
• Product Code: JDI
• UDI-Device Identifier: 10885862023421
• UDI-Public: 10885862023421
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/01/2025

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
• Device Expiration Date: 11/03/2014
• Device Catalogue Number: 132-36-53
• 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: 11/14/2025
• Initial Report FDA Received Date: 12/01/2025
• Date Device Manufactured: 11/12/2010
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Required Intervention
• Patient Sex: Male