MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 01/08/2024

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products bone screw 6.5mm dia x 25mm long (cat# 120-65-25 / serial# (b)(6).Element-stem, collared w/ha, std offset, sz 16 (cat# 164-03-16 / serial# (b)(6).Biolox delta femoral head 36mm od, +7mm (cat# 170-36-07 / serial# (b)(6).Integrip cc, cluster 60mm, g4 (cat# 186-01-60 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, surgeon reported a male patient's revision poly and head swap for an accu match cup.X-ray received.The devices are not available for evaluation.

• Brand Name: NV GXL LINR, NTRL, 36MM ID, GROUP 4 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18651209
• MDR Text Key: 334661712
• Report Number: 1038671-2024-00161
• Device Sequence Number: 1
• Product Code: JDI
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2015
• Device Model Number: NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
• Device Catalogue Number: 130-36-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male