MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number 130-36-53

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10.Concomitants: (b)(6).164-13-12 - novation element ro s/o col sz 12.(b)(6).170-36-03 - biolox delta femoral head 36mm od, +3.5mm.(b)(6).186-01-56 - integrip cc, cluster 56mm,g3.

Event Description

As reported via legal documentation, a patient had right hip replacement on (b)(6) 2014.They underwent right hip revision surgery on (b)(6) 2022, approximately 7 years 8 months post primary procedure.(b)(6) 2022 op report diagnosis: osteolysis and aggressive poly wear of the right total hip.Preoperative radiographs, x-rays confirmed osteolysis about the acetabulum and significant wear of the polyethylene.Ct documented osteolysis.During dislocation of the hip, it was noted that the head was removed without trauma to the trunnion, and there was no evidence of erosion present.The patient did have significant polyethylene reaction at the synovium.They had significant increase in fluid, but there was no evidence of muscle destruction.The femur was well fixed with minimal osteolysis at the edge.Patient tolerated the procedures, transferred to the recovery room.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

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 LINR, NTRL, 36MM ID, GROUP 3 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: 17451122
• MDR Text Key: 320382370
• Report Number: 1038671-2023-01853
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10885862022233
• UDI-Public: 10885862022233
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: 130-36-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2014
• 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: 64 YR