MAUDE Adverse Event Report: EXACTECH INC. NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 130-36-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 08/15/2022

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2017 and then experienced a revision surgical procedure on (b)(6) 2022 approximately 5 years and 7 months after initial implant.There is no device information provided.No other patient information / medical history reported.No images of the devices are provided.The device will not be returned.There is no other information available.

Manufacturer Narrative

H10: pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.Concomitants: 164-13-10 - novation element ro s/o col sz 10 4712224.170-36-00 - biolox delta femoral head 36mm od, +0mm 4661246.186-01-52 - integrip cc, cluster 52mm, g2 4679218.

• Brand Name: NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 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: 18958306
• MDR Text Key: 338341617
• Report Number: 1038671-2024-00642
• Device Sequence Number: 1
• Product Code: LZO
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Catalogue Number: 130-36-52
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2023
• Date Device Manufactured: 07/12/2016
• 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