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

Catalog Number 130-36-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 06/12/2023

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: (b)(4)-101-05-30 - 3.2mm drill bit30mm 1pk.(b)(4)-170-36-00 - biolox delta femoral head 36mm od, +0mm.(b)(4)-180-65-30 - alteon 6.5mm screw, 30mm.(b)(4)-186-01-52 - integrip cc, cluster 52mm, g2.(b)(4)-188-00-04 - wedge plasma s/o sz 4.Pending investigation.

Event Description

As reported via legal documentation the patient had a left hip replacement on (b)(6)2016.Approximately 6 years and 6 months after the initial procedure the patient had a left hip revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023.Diagnosis: left total hip wear of the acetabular liner a large amount of reactive synovitis around the acetabulum was found.This was removed.There was a large cyst that was easily visualized through the central hole of the acetabular liner.The was debrided out.The patient was transferred to the post anesthesia care unit in stable condition.

Manufacturer Narrative

The most likely cause for the revision reported due to prosthesis wear is a combination of risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.

• Brand Name: NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 18426925
• MDR Text Key: 331809492
• Report Number: 1038671-2024-00004
• Device Sequence Number: 1
• Product Code: JDI
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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: 09/11/2021
• Device Catalogue Number: 130-36-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• 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-1729-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male