MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 130-36-54

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 10/30/2023

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a left total hip replacement procedure on (b)(6)2013 and then was revised on (b)(6)2023.Patient required revision surgery for issues including but not limited to joint pain, limited range of motion, loss of mobility, revision surgery, and other injuries presently undiagnosed which will require on going medical care.The mostly likely cause for the revision reported due to prosthesis wear is a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

Manufacturer Narrative

D10: concomitant devices: 2331793 164-01-13 - element-stem, collarless w/ha, std offset, sz 13 2444910 120-65-20 - bone screw 6.5mm dia x 20mm long 2517501 148-36-93 - 12/14 zirconia head 36mm rep by 170-36-93 2527081 186-01-62 - integrip cc, cluster 62mm, g4 h3: the revision reported was likely the result of prosthesis wear of the tibial insert.The cause of prosthesis wear is generally a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.

• Brand Name: NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
• Type of Device: 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 ct; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19197754
• MDR Text Key: 341236423
• Report Number: 1038671-2024-00999
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862022240
• UDI-Public: 10885862022240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2017
• Device Catalogue Number: 130-36-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2012
• 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-1729-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male