MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant product - crown cup,cluster-hole gr.50 (cat# 180-01-50 / serial# (b)(6) ) additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by the germany competent authorities indicates that the patient had prostheses from exactech implanted on both sides.As part of the manufacturer's recall campaign, the patient presented for a check-up.In the x-ray control there was a clear decentering of both prosthetic heads and unusually large osteolysis in the acetabulum on the left and small osteolysis on the right as a sign of inlay wear.This could happen to one inlay change on february 5th, 2024 to a vitd-hardened, specially approved inlay (novation xle, neutral liner, group 2, 36 mm i.D., ref (b)(4), sn (b)(4)).A s part of the replacement operation, after the inlay exchange, the determination of the solid cup integrity as well as the curettage and sealing of the cysts socket bearing using allogeneic cancellous bone and changing the prosthetic head.The explants are currently in the laboratory doctor's office (for microbiological examination using sonication.After the examination has been completed (14 days of long-term incubation),.

• Brand Name: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 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 66 court; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18912405
• MDR Text Key: 337758539
• Report Number: 1038671-2024-00520
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862207074
• UDI-Public: 10885862207074
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/15/2024

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: 05/29/2022
• Device Model Number: NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
• Device Catalogue Number: 130-32-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male