MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 28MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 132-28-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

D10 concomitant products: 2450412 - 148-28-00 - 12/14 zirconia head 28mm +0mm neck 3552163 - 162-00-04 - neck preserving stem, std offset plasma sz 4 3848458 - 180-65-30 - alteon 6.5mm screw, 30mm 3845768 - 186-01-54 - integrip cc, cluster 54mm, g2 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.

Event Description

It was reported via legal documentation that a patient had a right total hip replacement procedure on (b)(6) 2015 and then was revised on (b)(6) 2024.Patient required revision surgery for issues including but not limited to polyethylene prosthesis wear, pain, and device failure.The mostly likely cause for the revision reported due to prothesis 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.

• Brand Name: NV GXL LNR, LIPPED, 28MM ID, GROUP 2 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: 19176069
• MDR Text Key: 340968971
• Report Number: 1038671-2024-00964
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862023162
• UDI-Public: 10885862023162
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/24/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2017
• Device Catalogue Number: 132-28-52
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2012
• 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: SEEH10
• Patient Outcome(s): Required Intervention