MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number 136-36-52

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10.Concomitants: 4343627 170-36-00 - biolox delta femoral head 36mm od, +0mm.4284798 180-01-52 - nv crown cup clstr hole 52mm group 2.4317553 180-65-20 - alteon 6.5mm screw, 20mm.3706124 180-65-35 - alteon 6.5mm screw, 35mm.4291326 188-00-08 - wedge plasma s/o sz 8.

Event Description

As reported via legal documentation, a patient had left hip replacement surgery on (b)(6) 2016.They subsequently underwent left hip revision surgery on (b)(6) 2023, approximately 6 years 10 months after their primary procedure.(b)(6) 2023 op report states that there was some mild osteolysis around the rim of the acetabulum, but the stem was well fixed and retained.The trunnion of the femoral head was noted to be in good condition.The acetabular liner had significant wear, some cracking along the superior rim of the acetabulum.The cup was well fixed and in good position.The central hole and around the rim did not indicate significant osteolytic defects; bone grafting was not needed.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

H10.Updated/additional information ¿ d5.G1.G2.G4.H6.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 cannot be not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.

• Brand Name: NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: matt collins ; 3523782617
• MDR Report Key: 17275471
• MDR Text Key: 318553361
• Report Number: 1038671-2023-01574
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2021
• Device Model Number: 136-36-52
• Device Catalogue Number: 136-36-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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: 61 YR
• Patient Sex: Female