MAUDE Adverse Event Report: EXACTECH, INC. NOVATION GXL LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that this 75 y/o, male patient's left hip was revised due to early wear of the gxl poly.Patient was last known to be in stable condition following the event.Device is returning.

Manufacturer Narrative

(h3) based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis.The prosthesis wear was able to be confirmed from the provided radiograph/explanted devices.

• Brand Name: NOVATION GXL LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15069796
• MDR Text Key: 296288401
• Report Number: 1038671-2022-00823
• Device Sequence Number: 1
• Product Code: MEH
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male