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 12/01/2023

Event Type  Injury  

Event Description

As reported by the germany competent authorities and as part of the manufacturer's recall campaign, the patient went to have the device implanted in 2019 checked left hip prosthesis.The x-ray control showed a clear decentering of the prosthetic head and unusually large osteolysis in the acetabulum as a sign of inlay wear.This could happen to one inlay change on (b)(6) 2023 to a vitd-hardened, specially approved inlay novation xle neutral liner, group 1, 32mm (cat# 140-32-51 / serial# (b)(6)).As part of the replacement operation, the inlay exchange, determination of solid cup integrity as well as 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.Surgical reports/x-rays are also available upon request.Hospital data of the implantation and replacement, as well as photos of the explants, will be sent upon receipt.

Manufacturer Narrative

Section d10: concomitant products: 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.

• 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: miguel soza
• MDR Report Key: 18395374
• MDR Text Key: 331359366
• Report Number: 1038671-2023-03058
• 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: 12/26/2023

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: 07/26/2023
• 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: 12/05/2023
• Initial Date FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female