MAUDE Adverse Event Report: EXACTECH INC. NOVATION GXL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 06/14/2023

Event Type  Injury  

Manufacturer Narrative

H10.Pending investigation.There is no other information available.

Event Description

It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2018 and then experienced a revision surgical procedure on (b)(6)2023 approximately 4 years and 8 months after initial implant.There is no device information provided.No other patient information / medical history reported.No images of the devices are provided.The device will not be returned.There is no other information available.

Manufacturer Narrative

H10.Updated / additional information - g1, g3, g6, h1, h6 (component code as liner).H6.Investigation results - the most 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 may have also been a contributing factor to the early prosthesis wear.However, this is not confirmed, the devices were not returned.These devices are used for treatments, not diagnosis.There is no other information available.

• Brand Name: NOVATION GXL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: matt collins
• MDR Report Key: 18710199
• MDR Text Key: 335411773
• Report Number: 1038671-2024-00228
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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