MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 130-32-51

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 02/09/2022

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a left total hip arthroplasty on (b)(6) 2018 and then approximately 3 years 8 months later on (b)(6) 2022 had a surgical revision.There is no other information provided/available.

Manufacturer Narrative

D10.Concomitant products: (b)(6) - 120-65-15 - bone screw 6.5mm dia x 15mm long.(b)(6) - 164-13-09 - novation element ro s/o col sz 9.(b)(6) - 170-32-00 - biolox delta femoral head 32mm od, +0mm.(b)(6) - 186-01-48 - integrip cc, cluster 48mm, g1.These devices are used for treatment not diagnosis.There is no other information available.Pending investigation.

• Brand Name: NV GXL LINER
• 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: matt collins
• MDR Report Key: 19160398
• MDR Text Key: 340803840
• Report Number: 1038671-2024-00936
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862207074
• UDI-Public: 10885862207074
• 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: 04/22/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 08/30/2016
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention