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

Model Number NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Cyst(s) (1800)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported that a 70 yo male patient, initial hip prosthetic socket implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2024, approximately 5 years 10 months post the initial procedure.As part of the manufacturer's recall campaign, the patient presented for a check-up.The x-ray and ct check showed a slight decentration of the prosthetic head and a cystic mass in the area acetabulum as a sign of inlay wear.This was confirmed when the inlay was changed on (b)(6) 2024 to a vitd-hardened, specially approved inlay (novation xle, neutral liner, group 2, 32mm i.D., ref 140-32-52, sn (b)(6)) be verified.As part of the replacement operation, in addition to the inlay replacement, the firmness was determined, cup integrity as well as the curettage of the cyst in the socket and the replacement of the prosthetic head.No further information.

Manufacturer Narrative

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

• 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: 18882737
• MDR Text Key: 337410721
• Report Number: 1038671-2024-00467
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862022165
• UDI-Public: 10885862022165
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2022
• Device Model Number: NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Date Device Manufactured: 08/04/2017
• 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-1729-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male