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	Local Reaction (2035); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10.(b)(6); 130-36-52 - nv gxl liner neutral, 36mm id, group 2 cups.(b)(6); 142-36-03 - cocr fem head 36mm +3.5 offset 12/14.(b)(6); 160-30-12 - pf spline plasma w/ha sz 12.(b)(6); 180-01-54 - nv crown cup clstr hole 54mm group 2.(b)(6); 180-65-25 - alteon 6.5mm screw, 25mm.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 review of manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.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
It was reported that the patient underwent an initial right hip replacement.Subsequently, the patient reported "having issues" and that their surgeon confirmed the presence of particle disease.Details regarding the origin and nature of the particulate debris and the manifestation(s) of the particle disease in the patient were not provided.At the time of reporting, no medical intervention has been indicated.No further patient impact was reported.No additional information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Based on the available information, the patient involved in this event meets the following risk criteria for early prosthesis wear and/or osteolysis as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely cause for the reported prosthesis wear in this event 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.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21516082
• Report Number: 1038671-2025-01384
• Device Sequence Number: 7974483
• Product Code: JDI
• UDI-Device Identifier: 10885862207081
• UDI-Public: 10885862207081
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 05/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2022
• Device Catalogue Number: 130-36-52
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2017
• 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: Other
• Patient Sex: Male