MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; GXL NUETRAL LINER, G0 28MM ID

Catalog Number 130-28-50

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

As a result of an fda inspection conducted in (b)(6) 2020, exactech, fei 1038671, has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.Design-related issues: exactech is aware of 61 complaint reports involving hip components due to prothesis wear (11 non-revisions and 50 revisions) since 2008.The frequency of occurrence ranking scale is very low; therefore, this issue does not appear to be design related.Mfg-related issues: exactech is not aware of any other complaints involving parts from this manufacturing lot.According to the sales data, all pieces of the 42-piece lot have been sold.The device history record for the acetabular liner was reviewed, and all parts were accepted with conformance to the device specifications.Therefore, this issue does not appear to be manufacturing related.Corrective actions are not required because prothesis wear is listed in the hip implant product labeling, the occurrence rate is ¿very low¿, and the risk is captured in the rmr.The prothesis wear reported in experience c2018-756 was likely the result of polyethylene wear accelerated by edge loading or neck impingement.However, the underlying cause of prothesis wear cannot be determined because the patient was not revised, and the device was not available for evaluation.Ifu 700-096-181: instrument inspection: visually inspect the instruments for damage such as fractures; cracks; gouges; deformation; burrs; discoloration, corrosion, or rust; excessive component wear; nicks on cutting surfaces, missing or loose components; blockages in cannulae, cleaning holes or other cavities that cannot be removed via standard cleaning; worn or difficult to read markings/engravings; or other apparent damage.Check the function of mechanisms by actuating any levers, knobs, switches, connectors, sliding features, hinges, or other mechanical interface features.Ensure smooth operation of these features over their functional range of motion.If damage, wear, or non-functioning/poorly functioning mechanisms are found, do not use the instrument, and contact the sales representative or customer service for disposition.Ifu states: the surgeon shall become thoroughly familiar with the technique of implantation of the prostheses by: appropriate reading of the literature, and training in the operative skills and techniques required for surgery, and reviewing information regarding use of instrumentation.It is a clinical standard of practice in the operating room that all instruments should be visually and functionally inspected before use, these guidelines are from standard association of peri-operative registered nurses (aorn) guidelines.Surgeons are to be familiar and knowledgeable with all instrumentation, devices and proficient with surgical techniques.This device is used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any manufacturing issues or design issues.As of (b)(6) 2021, it is unknown if the 84 yo patient had a surgical revision.An investigation was conducted; the prothesis wear reported was likely the result of polyethylene wear accelerated by edge loading or neck impingement.However, the underlying cause of prothesis wear cannot be determined because the patient was not revised, and the device was not available for evaluation.When the company is notified of patient revision the file will be updated and assessed for mdr serious injury.

Event Description

It was reported from ous that a doctor had identified a case of premature poly wear in a patient that was implanted on (b)(6) 2013.The patient did not want to have a revision, as of (b)(6) 2021 it is unknown about the patient¿s condition or revision status.Multiple email requests were sent to the contacts for additional information.No further information has been provided by the contacts related to this event.

• Brand Name: EXACTECH
• Type of Device: GXL NUETRAL LINER, G0 28MM ID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 13899956
• MDR Text Key: 298161669
• Report Number: 1038671-2022-00277
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K100269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130-28-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/22/2018
• Date Manufacturer Received: 11/22/2018
• Date Device Manufactured: 03/09/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 68 KG