MAUDE Adverse Event Report: EXACTECH, INC. NOVATION G3 EXT COVERAGE LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

H3: pending investigation.

Event Description

It was reported that a patient, who had an initial left hip implanted on an unknown date, underwent a revision procedure on (b)(6) 2024.The screws were removed and replaced with three new screws.The extended coverage liner was replaced with a face changing g3 36 liner.The cocr head was replaced with one of the same size.There were no device breakages or surgical delays during the procedure.No x-rays were able to be obtained.The patient was last known to be in stable condition following the event.No explanted devices are available for return and not device images were able to be provided.No further information.

• Brand Name: NOVATION G3 EXT COVERAGE LINER
• 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: 19087451
• MDR Text Key: 339909249
• Report Number: 1038671-2024-00790
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention