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 Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Loss of Range of Motion (2032); Anxiety (2328); Ankylosis (4527); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: no concomitants available.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 68 months after a left total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, limited rom, loss of mobility, anxiety, and emotional distress.No further issues or complications were reported.No additional information is available.
Event or Problem Description
It was reported via legal documentation that approximately 68 months after a left total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, joint pain, limited rom, loss of mobility, anxiety, and emotional distress.Post operative report was provided.Surgeon observed superior wear on the polyethylene liner, abductor weakness with lurch, tear of gluteus minimus and medius with bald trochanter.Acetabulum was noted with no movement and stable.The stem was well fixed.No signs of infection.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Added fields: a2, a3 and g2 corrected fields: d4, d10, g3, h6: investigation codes.D10: (b)(6) 186-03-56 - integrip mh cup sz 56mm.(b)(6) 170-36-50 - biolox delta option femoral head 36mm od.(b)(6) 170-50-07 - biolox delta adapter 16/18-12/14; +7mm.(b)(6) 180-65-15 - alteon 6.5mm screw, 15mm.(b)(6) 180-65-15 - alteon 6.5mm screw, 15mm.(b)(6) 180-65-15 - alteon 6.5mm screw, 15mm.(b)(6) 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6) 180-65-25 - alteon 6.5mm screw, 25mm.(b)(6) 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6) 180-65-40 - alteon 6.5mm screw, 40mm.
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 due to prosthesis wear, loss of range of motion and osteolysis is a combination of the risk factors specified 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 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19481560
• Report Number: 1038671-2024-01774
• Device Sequence Number: 20814309
• 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: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2025

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: 06/25/2022
• Device Catalogue Number: 132-36-53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: Not provided; 02/25/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 12/10/2024; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• 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; SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female