MAUDE Adverse Event Report: EXACTECH, INC. GXL NUETRAL LINER, G0 28MM ID; SEE H10

Catalog Number	130-28-50
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient received a right total hip arthroplasty on 25 mar 2019, and then approximately 4 years, 5 months later on 6 sep 2023 had a surgical procedure to replace the liner with another exactech device.The patient complains of pain, stiffness, discomfort, and weakness which in turn negatively affected mobility and quality of life.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.No images or photos of the device are provided.The device will not be returned.No other information is available.
Additional Manufacturer Narrative
D2b.Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented.D10.Concomitants: 5322718 170-28-93 - biolox delta femoral head 28mm od, -3.5mm.5486890 180-01-46 - cup, cluster-hole, 46mm group 0.5795047 188-01-04 - wedge plasma x/o sz 4.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Additional 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: GXL NUETRAL LINER, G0 28MM ID
• Common Device Name: 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: 17911719
• Report Number: 1038671-2023-02499
• Device Sequence Number: 15327798
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K100269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2019
• Device Catalogue Number: 130-28-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 02/27/2024; 08/24/2026
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 03/28/2024; 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1731-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female