MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 130-40-54

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Failure of Implant (1924); Osteolysis (2377)

Event Date 06/12/2023

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: (b)(6) 180-65-40 - alteon 6.5mm screw, 40mm.(b)(6) 170-40-00 - biolox delta femoral 40mm od, +0mm.Pending investigation.

Event Description

As reported via legal documentation the patient had a left hip revision on (b)(6) 2018.Approximately 4 years and 11 months after the first revision the patient had a second left hip revision on (b)(6) 2023.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.Revision op report on (b)(6) 2023.Diagnosis: failed left total hip replacement.The patient had extensive scarring.The patient encountered a huge adverse local tissue reaction and a large fluid collection and a dark gray trochanteric bursitis that had to be debrided.There was an opening breaking through to his greater trochanter that the surgeon thought contributed to trochanter was fractured.This had to all be curettaged and bone grafted.The acetabular component also had osteolysis that had required extensive curratage and bone grafting.

Manufacturer Narrative

H3: the revision reported was likely the result of the osteolysis and bone fracture.Osteolysis of the recalled gxl polyethylene was also identified in the revision operative notes.The osteolysis may have been the result of a combination of the risk factors specified in the hhe.However, the osteolysis and bone fracture cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.Correction: h6 clinical code.

• Brand Name: NV GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS
• 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 66th ct.; gainesville FL
• Manufacturer Contact: miguel sosa
• MDR Report Key: 18482904
• MDR Text Key: 332545037
• Report Number: 1038671-2024-00064
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862207104
• UDI-Public: 10885862207104
• 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
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/09/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2021
• Device Catalogue Number: 130-40-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 08/01/2024
• Supplement Dates FDA Received: 08/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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-1732-2022
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male