MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	130-40-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 180-11-56 nv crown cup clsr hl w/ha 56 group 3: sn# (b)(6), 164-03-13 element-stem, collared w/ha, std offset, sz 13: sn#(b)(6), 01-032-03-4094 universal cup, head, delta, 40mm, -4: sn# (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported a 56 yo male patient, who had thas in both hips, indicated that after some time with pain and loss of mobility in their left leg, they went to the traumatologist's check-up and they informed him that the prosthesis is totally worn out and that it must be changed urgently because it has already begun to affect the adjacent bone.He is with the preoperative, and the intervention is scheduled at a future date.Additionally, the patient reported complications in the right requiring crutches for support and a 70% and total disability.This is 1 of 2 events for this patient.(b)(4).Right hip event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11.The devices were not returned for analysis.No images, radiographs, or patient information were provided.The hhe noted, there is evidence that a moderately higher risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.A number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis.Additionally, increased shelf oxidation resulting from the use of nylon vacuum bags without evoh could also have contributed to the increased trend in wear/osteolysis.Patients with increased risk tend to present with signs for prosthesis wear and subsequent particle-induced osteolysis within the first 5 years after the index arthroplasty and have the following characteristics: significant edge loading of the femoral head on the acetabular liner, patients implanted with a lateralized liner, patients in whom the largest available femoral head and/or thinnest available acetabular liner was used, and patients implanted with a component having a shelf age of greater than 2 years.Those patients having a combination of risk factors will have the highest risk for early wear and lysis.This patient was implanted with a combination of the largest available femoral head and/or the thinnest available acetabular liner was used and implanted with a component having a shelf age of greater than 2 years.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: NV GXL LINER NEUTRAL, 40MM 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 23865007
• Report Number: 1038671-2025-03592
• Device Sequence Number: 17475430
• Product Code: JDI
• UDI-Device Identifier: 10885862207098
• UDI-Public: 10885862207098
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 10/24/2020
• Device Catalogue Number: 130-40-53
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male