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

Catalog Number 130-36-54

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

H10.D10.Concomitants: 4118946 - 164-01-12 - element-stem, collarless w/ha, std offset, sz 12 4487770 - 170-36-07 - biolox delta femoral head 36mm od, +7mm 4414694 - 186-03-60 - integrip mh cup sz 60mm.These devices are used for treatments, not diagnosis.There is no other information available.

Event Description

It was reported via legal documentation that a patient had a left total hip arthroplasty on (b)(6) 2016, and then experienced revision surgical procedure on (b)(6) 2023 approximately 6 years and 9 months after initial implant.No images were provided.There is no other information available.

• Brand Name: NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19170986
• MDR Text Key: 340898958
• Report Number: 1038671-2024-00961
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862022240
• UDI-Public: 10885862022240
• 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: 04/24/2024

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: 07/07/2020
• Device Catalogue Number: 130-36-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 04/24/2024
• Date Device Manufactured: 07/10/2015
• 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
• Patient Outcome(s): Required Intervention