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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2023

Event Type  Injury  

Event Description

It was reported, a 66 yo female patient, initial right hip implanted on an unknown date, underwent a revision procedure on (b)(6) 2023, due to right hip issues and a recalled implant.¿the patient had to undergo revision right hip surgery due to the novation gxl hip poly liner recall¿.The patient was revised to a "g2" novation xle vitamin e 10-degree face changing liner for a 36mm id and a 36mm ceramic head with +0 mm adaptor sleeve.There was greater than a 45-minute surgical delay during the procedure, with no adverse event to the patient as a result.Patient was last known to be in stable condition following the event.It is not known if implants are available for return as the rep was not present for the case.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

Based on review of all available information, there is no evidence or report to suggest that the event is related to failure of the device to meet specifications, the device was inspected and released for distribution.The cause of the patient¿s pain and subsequent revision 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.

• Brand Name: NOVATION GXL
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16416850
• MDR Text Key: 309965983
• Report Number: 1038671-2023-00195
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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,Followup
• Report Date: 06/01/2023

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: 01/26/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female