MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number 130-36-52

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 03/05/2022

Event Type  Injury  

Event Description

As reported via legal documentation, a patient had left hip replacement surgery on (b)(6) 2014.They underwent left hip revision surgery on (b)(6) 2022, approximately 7 years 10 months post primary procedure.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

Pending investigation.

Manufacturer Narrative

As a result of additional information and investigation findings, the following fields have been updated: a2, a3, b5, d1, d4, d10, g4, h4, h6, h7, and h9.D10.Concomitants: 2199490 164-02-10 - element-stem, collarless w/ha, high offset, sz 10.2978058 170-36-93 - biolox delta femoral head 36mm od, -3.5mm.2994984 186-01-54 - integrip cc, cluster 54mm, g2.H6: investigation results - the revision reported was likely the result of the patient¿s fall and subsequent bone fracture.Wear of the recalled gxl polyethylene was also identified in the revision operative notes.The wear/osteolysis may have been the result of a combination of the risk factors.However, this cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.

Event Description

Additional information: revision postoperative diagnosis 1.Failed left total hip arthroplasty.2.Left periprosthetic femur shaft fracture (displaced oblique).3.Left femur shaft deformity.4.Standing high fall trauma mechanism.

• Brand Name: NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: miguel sosa ; 3523782617
• MDR Report Key: 17447190
• MDR Text Key: 320279133
• Report Number: 1038671-2023-01845
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862207081
• UDI-Public: 10885862207081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/24/2019
• Device Catalogue Number: 130-36-52
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1732-2022
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female