MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 67 yo male patient, initial hip implanted on (b)(6), 2012, underwent a revision procedure on (b)(6), 2024, approximately 11 years 5 months post the initial procedure.The patient was implanted with a hip prosthetic cup from exactech in 2012.In the case of mild stress-related symptoms, a check was carried out in 2018, but there was no evidence of this inlay wear.As part of the manufacturer's recall campaign, the patient presented for a new check-up.The x-ray and ct check showed a clear decentering of the prosthetic head as a sign of inlay wear with only small lysis in the acetabulum.This was confirmed when the inlay was changed on (b)(6), 2024 to a vite-hardened special approved inlay (novation xle, neutral liner, ref 140-36-53, sn (b)(6)).As part of the replacement operation, in addition to the inlay replacement, the firmness was determined, cup integrity, as well as, the curettage and sealing of the cysts in the socket using allogeneic cancellous bone and changing the prosthetic head.No further information.

Manufacturer Narrative

(h3) the revision reported was likely the result of prosthesis wear and osteolysis.The extent and root cause of the wear and osteolysis could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.

• Brand Name: NOVATION
• 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 sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18927434
• MDR Text Key: 337944881
• Report Number: 1038671-2024-00552
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862022233
• UDI-Public: 10885862022233
• 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
• Report Date: 03/18/2024

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: 12/06/2014
• Device Model Number: NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS
• Device Catalogue Number: 130-36-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/18/2024
• Date Device Manufactured: 12/14/2010
• 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
• Treatment: (B)(6) 180-01-58 - CROWN CUP,CLUSTER-HOLE GR.58.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male