MAUDE Adverse Event Report: EXACTECH INC. NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 130-28-51

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 10/09/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: 5199027, 190-10-02 - alt ha clr std sz 2.5292175, 170-28-03 - biolox delta femoral head 28mm od, +3.5mm.6334662, 186-01-48 - integrip cc, cluster 48mm, g1.S069531, 180-65-35 - alteon 6.5mm screw, 35mm.These devices are used for treatments.Not diagnosis.Pending investigation.There is no other information available.

Event Description

It was reported via legal documentation that a patient had a left total hip arthroplasty on (b)(6) 2020 and then experienced a revision surgical procedure on (b)(6) 2023 approximately 3 years and 3 months after initial implant.Revision op report stated that the polyethylene liner had significant catastrophic wear.No images of the devices are provided.The device will not be returned.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 LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: matt collins
• MDR Report Key: 18722947
• MDR Text Key: 335599053
• Report Number: 1038671-2024-00243
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070479
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2021
• Device Catalogue Number: 130-28-51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2016
• 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: 60 YR
• Patient Sex: Female