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

Model Number NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2023

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) 2019, underwent a revision procedure on (b)(6) 2023, approximately 4 years 6 months post the initial procedure.As part of the manufacturer's recall campaign, the patient presented himself for a checkup of the devices implanted in his 2019 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.The gxl insert was replaced with an 140-36-53 cc inlay vitamin e, neutral, ø 36, gr.3.As part of the replacement operation, the inlay was exchanged, 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 was performed.Device returns available if the patient makes them available.No further information.

Manufacturer Narrative

H3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified: implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to early prosthesis wear is a combination of the risk factors specified.However, prosthesis wear cannot be confirmed as radiographs and the devices were not available for evaluation.

• 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: 18351807
• MDR Text Key: 330810078
• Report Number: 1038671-2023-03016
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10885862022172
• UDI-Public: 10885862022172
• 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: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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: 03/13/2022
• Device Model Number: NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS
• Device Catalogue Number: 130-32-53
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/06/2024
• Date Device Manufactured: 03/15/2017
• 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
• Treatment: (B)(6) 180-01-58 - CROWN CUP,CLUSTER-HOLE GR.58
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male