MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; SEE H10

Catalog Number 130-32-51

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 08/28/2023

Event Type  Injury  

Manufacturer Narrative

D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented d10.Concomitants: sn (b)(6), cat # 170-32-00 - biolox delta femoral head 32mm od, +0mm.Sn (b)(6), cat # 186-01-48 - integrip cc, cluster 48mm, g1.Sn (b)(6), cat # 188-01-10 - wedge plasma x/o sz 10.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 left hip arthroplasty on (b)(6) 2016, and reported pain, stiffness, discomfort, and weakness which in turn negatively affected mobility and quality of life and necessitated a revision surgery and the resultant pain following surgery and recuperation/rehabilitation period and physical therapy.It was later reported that the patient had a revision of the left hip for recalled poly on (b)(6) 2023, approximately 6 years 10 months after initial implant.X-rays/photos were unable to be obtained.There was no surgical delay.There was no breakage of devices during surgery.There will be no device return, the hospital kept device.Patient was last known to be in stable condition following the event.The patient was revised to exactech devices.There is no other information available.

Manufacturer Narrative

H6.Investigation results - 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 is not confirmed, the devices were not returned.These devices are used for treatments, not diagnosis.There is no other information available.

• Brand Name: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
• Type of Device: SEE H10
• 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 ; 3523771140
• MDR Report Key: 17719499
• MDR Text Key: 323067875
• Report Number: 1038671-2023-02228
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2021
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2016
• 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
• Patient Age: 50 YR
• Patient Sex: Female