MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 130-36-53

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/29/2022

Event Type  Injury  

Manufacturer Narrative

H10.D10.Concomitants - product information: 2908048 101-05-30 - 3.2mm drill bit30mm 1pk; 3948487 170-36-00 - biolox delta femoral head 36mm od, +0mm; 3678854 180-65-20 - alteon 6.5mm screw, 20mm; 3857998 186-01-58 - integrip cc, cluster 58mm, g3; 3825127 188-01-11 - wedge plasma x/o sz 11.Pending investigation.There is no other information available.

Event Description

It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2015, and then experienced a revision surgical procedure on (b)(6) 2022, approximately 7 years, 5 months after initial implant.There was no other patient/medical information provided.No x-rays or images were provided.The device will not be returned.There is no other information available.

• Brand Name: NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: michael crader
• MDR Report Key: 18956354
• MDR Text Key: 338308891
• Report Number: 1038671-2024-00634
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862022233
• UDI-Public: 10885862022233
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2020
• Device Catalogue Number: 130-36-53
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2023
• Date Device Manufactured: 01/19/2015
• 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 Outcome(s): Required Intervention