MAUDE Adverse Event Report: EXACTECH, INC. NOVATION GXL; SEE H10

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

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 02/18/2016

Event Type  Injury  

Event Description

As reported via legal documentation the patient had a right hip replacement on (b)(6) 2016.Device has not been explanted.The patient has suffered the following injuries and complications: osteolysis, loosening of hip prosthesis, degradation of hip prosthesis, swelling, edema, restricted motion and pain.Full extent unknown.Upon information and belief, the patient will be required to undergo right hip revision surgery in or around early winter, 2023-2024.There is no other patient demographic or medical history available.No additional information is available.

Manufacturer Narrative

D2b.Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented.H6.Investigation results - there is no specific novation gxl device information provided.The cause of the patient¿s pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.There is no other information available.

Manufacturer Narrative

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 cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.

• Brand Name: NOVATION GXL
• Type of Device: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: matt collins
• MDR Report Key: 17237772
• MDR Text Key: 318202784
• Report Number: 1038671-2023-01514
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100269
• 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: 04/10/2024

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
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/10/2024
• 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