MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS; SEE H10

Catalog Number 130-36-52

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 06/08/2023

Event Type  Injury  

Event Description

As reported via legal documentation.This patient had a right hip revision approximately 4 years after initial implant.Revision operative report of (b)(6) 2023.Postoperative diagnosis: failed right total hip replacement secondary to exactech polyethylene recall.Pseudocapsule excised, hip dislocated, head removed from the neck.Thorough debridement carried out of the proximal femur.There was some myolysis here.This was debrided and the femoral component checked and noted to be stable.Retractors were then placed at the bony acetabular margin.Thorough debridement was carried out of soft tissue around the periphery and then the polyethylene removed from the shell.There was significant wear superolaterally.Sterile dressing was applied.The patient was awakened and returned to the recovery room in stable condition.No intraoperative complications.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.

Manufacturer Narrative

D2b.Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented.D10.Concomitants: 170-36-93 - biolox delta femoral head 36mm od, -3.5mm; sn (b)(6), 180-01-54 - nv crown cup clstr hole 54mm group 2; sn (b)(6), 180-65-30 - alteon 6.5mm screw, 30mm, sn (b)(6), 188-01-09 - wedge plasma x/o sz 9, sn (b)(6).These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.

Manufacturer Narrative

H10.Updated / additional information - g1, g3, g6, h1, h6 (component code as liner).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, 36MM ID, GROUP 2 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: 17729889
• MDR Text Key: 323191573
• Report Number: 1038671-2023-02241
• 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,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2021
• Device Catalogue Number: 130-36-52
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• 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: 66 YR
• Patient Sex: Female