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

Catalog Number	130-36-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 186-01-56 - integrip cc, cluster 56mm,g3 (b)(6) 170-36-03 - biolox delta femoral head 36mm od, +3.5mm (b)(6) 188-01-11 - wedge plasma x/o sz 11 (b)(6) 101-45-20 - 4.5mm drill bit 20mm (b)(6) 180-65-30 - alteon 6.5mm screw, 30mm (b)(6).
Event or Problem Description
It was reported that a 63 yo male patient, initial right hip implanted in (b)(6) 2015, underwent a revision procedure in (b)(6) 2024, approximately 9 years 2 months post the initial procedure.The patient returned to the surgeon¿s office with complaints of pain, and dissatisfaction with their hip.Upon examination, the patient has a recalled poly liner.The patient was scheduled for a revision total hip replacement possible poly liner and femoral head swap.The patient had revision surgery and underwent a poly acetabular liner swap and a femoral head swap.They were revised to nv ehxl ntrl lnr g3 40mm (b)(6) biolox delta adapter 16/18-12/14; +3.5mm b110877 biolox delta option femoral head 40mm od (b)(6).There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were available.The explanted devices are not available for analysis.They were sent to the lab and legal hold at the hospital.No device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely cause for the reported revision is a combination of the risk factors: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV GXL LINR, NTRL, 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20616578
• Report Number: 1038671-2024-04258
• Device Sequence Number: 15672100
• Product Code: JDI
• UDI-Device Identifier: 10885862022233
• UDI-Public: 10885862022233
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2020
• Device Catalogue Number: 130-36-53
• 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: 10/27/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• 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: 63 YR
• Patient Sex: Male