MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 36MM ID GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number NV GXL LINER LIPPED 36MM ID GROUP 2

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 12/01/2023

Event Type  Injury  

Event Description

As reported, approximately six years post initial tha, the male patient was revised due to pain.Poly wear was noted by surgeon.A new vit e liner and ceramic head were implanted.There was no issues with surgery.Photos received.The devices are not available for evaluation.

Manufacturer Narrative

Section d10: concomitant products.Biolox delta femoral head 36mm od, +0mm (cat# 170-36-00 / serial# (b)(6).Alteon 6.5mm screw, 30mm (cat# 180-65-30 / serial# (b)(6).Integrip cc, cluster 54mm, g2 (cat# 186-01-54 / serial# (b)(6).Wedge plasma x/o sz 10 (cat# 188-01-10 / seral# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

H3.Investigation results- based on the available information, the patient involved meets risk criteria for early prosthesis wear -combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.These devices are used for treatment not diagnosis.There is no other information available.

• Brand Name: NV GXL LINER LIPPED 36MM ID GROUP 2
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 18395188
• MDR Text Key: 331358327
• Report Number: 1038671-2023-03055
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862207036
• UDI-Public: 10885862207036
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: NV GXL LINER LIPPED 36MM ID GROUP 2
• Device Catalogue Number: 132-36-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2018
• 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: UNK.
• Patient Outcome(s): Required Intervention