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 Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

H10.D10.Concomitants: 6138399, 180-11-54- nv crown cup clsr hl w/ha 54 group 2.*unk - 01-032-03-3694 universal cup, head, delta, 36mm, -4.*(1902.8230.217/027 - provided as sn, but this is not a sn).These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.

Event Description

It was reported via legal documentation that a patient had a total hip arthroplasty on (b)(6) 2019 and then approximately 4 years, 5 months later on (b)(6) 2024 experienced a surgical revision.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No other information is available.

• 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: matt collins
• MDR Report Key: 19181673
• MDR Text Key: 341044352
• Report Number: 1038671-2024-00978
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/25/2024

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: 05/21/2022
• Device Catalogue Number: 130-36-52
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2024
• Initial Date FDA Received: 04/25/2024
• Date Device Manufactured: 05/22/2017
• 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
• Patient Sex: Male