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

Model Number NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: (b)(6) - 101-05-30 - 3.2mm drill bit30mm 1pk; (b)(6) - 170-36-00 - biolox delta femoral head 36mm od, +0mm; (b)(6) - - 170-36-03 - biolox delta femoral head 36mm od, +3.5mm; (b)(6) - 180-65-30 - alteon 6.5mm screw, 30mm; (b)(6) - 186-01-52 - integrip cc, cluster 52mm, g2; (b)(6) - 88-00-09 - wedge plasma s/o sz 9.

Event Description

It was reported that a 75 yo female patient, initial left hip implanted on (b)(6) 2015, underwent a revision procedure on (b)(6) 2024, approximately 8 years 3 months post the initial procedure.The patient returned to the surgeon¿s office complaining of pain and dissatisfaction with their left primary hip.Upon examination and imaging the poly showed to be worn.The patient underwent revision left tha on (b)(6) 2024 where the head and poly liner were swapped.They were revised to a a775442 170-50-07 biolox delta adapter 16/18-12/14; +7mm, a656487 170-36-50 biolox delta option femoral head 36mm od, and a 6348964 140-36-52 nv ehxl ntrl lnr g2 36mm.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for return as they are sent to the lab and legal at the hospital and are not give to the rep.No device images were provided.No further information.

• Brand Name: NOVATION
• 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: matt collins ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19160833
• MDR Text Key: 340790835
• Report Number: 1038671-2024-00938
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862207081
• UDI-Public: 10885862207081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Expiration Date: 11/18/2020
• Device Model Number: NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS
• Device Catalogue Number: 130-36-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 11/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1732-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 63 KG