MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; 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 Osteolysis (2377)

Event Date 01/12/2024

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 79 yo female patient, initial hip implanted on (b)(6) 2020, underwent a revision procedure on (b)(6) 2024, approximately 3 years 3 months post the initial procedure.As part of the manufacturer's recall campaign, the patient presented herself for a check on the hip prosthesis implanted in 2020.The x-ray control showed a clear decentering of the prosthetic head unusually large osteolysis in the acetabulum as a sign of premature inlay wear.The inlay was changed on (b)(6) 2024, to a vitd-hardened, specially approved inlay (novation xle, extended coverage liner, ref 142-32-61, sn (b)(6)).After the inlay exchange, the determination of the solid cup integrity as well as the curettage and sealing of the cysts.Socket bearing using allogeneic cancellous bone and changing the prosthetic head was performed.No device returns for analysis available.No further information.

Manufacturer Narrative

After further review of additional information received the following sections g3, h2, h3 and h6 have been updated accordingly.(h3) based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as 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/osteolysis is a combination of the risk factors including, use error, implant positioning, implant size selection, and patient factors may have also been a contributing factor to the early prosthesis wear.However, this cannot be confirmed from the reported information.

• 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: 18704365
• MDR Text Key: 335369117
• Report Number: 1038671-2024-00216
• 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,Followup
• Report Date: 04/30/2024

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: 08/12/2023
• 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: 01/16/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2018
• 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
• Treatment: 6085868 186-01-50 - INTEGRIP CC,CLUSTER HOLE Ø 50
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female