MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 136-36-53

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): 4209539 170-36-07 - biolox delta femoral head 36mm od, +7mm.S036685 180-65-20 - alteon 6.5mm screw, 20mm.S041638 180-65-20 - alteon 6.5mm screw, 20mm.6169618 186-01-56 - integrip cc, cluster 56mm,g3.6295755 190-30-08 - alt ha s clr std sz 8.

Event Description

Experience report - usa patient id: (b)(6) as reported, the patient had an initial right tha on (b)(6) 2020.The patient had a revision of the cup and gxl liner to competitor devices on (b)(6) 2024; reason not reported.The stem was retained and a new head ball was implanted.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19112162
• MDR Text Key: 340227370
• Report Number: 1038671-2024-00851
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862024336
• UDI-Public: 10885862024336
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/15/2024

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: 08/22/2020
• Device Catalogue Number: 136-36-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2015
• 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-1729-2022
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Sex: Male