MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 12/07/2023

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products.Crown cup,cluster-hole gr.60 (cat# 180-01-60 / 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 and as part of the manufacturer's recall campaign, the male patient presented himself for a check-up of the device implanted in 2012 hip prosthesis on the right.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.In the supplementary ct examination also revealed partial cortical destruction of the inner wall of the pelvis.During the audit surgery on (b)(6) 2023, patient required a socket change to competitor¿s devices.As part of the replacement operation, the curettage and filling of the cyst in the socket using allogeneic spongiosa and the replacement of the prosthetic head.The explants are currently in the laboratory doctor's office for microbiological examination using sonication.

Manufacturer Narrative

Section h10: (h3) the revision reported may have been due to a combination of the risk factors specified in an hhe and/or from being implanted for over 10 years which led to prosthesis wear and osteolysis.However, this cannot be confirmed because the component was not returned for evaluation and radiographs were not provided.

• Brand Name: NV GXL LINR, NTRL, 36MM 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18468442
• MDR Text Key: 332374066
• Report Number: 1038671-2024-00039
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862022240
• UDI-Public: 10885862022240
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070479
• 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,Followup
• Report Date: 04/23/2024

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: 12/07/2013
• Device Model Number: NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS
• Device Catalogue Number: 130-36-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2009
• 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 Sex: Male