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 Insufficient Information (4580)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitant: 3765460 180-01-52 - crown cup, cluster-hole gr.52.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 69 yo female patient, initial left hip implanted on (b)(6) 2015, underwent a revision procedure on (b)(6) 2024, approximately 8 years 11 months post the initial procedure.As part of the manufacturer's recall campaign, the patient went to have the left hip prosthesis device implanted in 2015 checked.The x-ray control showed a clear decentering of the prosthetic head and osteolysis in the acetabulum as a sign of inlay wear.This was confirmed with an inlay change on (b)(6) 2024, to a vitd-hardened, specially approved inlay (novation xle, extended coverage liner size 2, 36 mm i.D., ref 142-36-62, sn: (b)(6).As part of the replacement operation, the inlay was replaced.Determination of the solid cup integrity as well as the curettage and sealing of the cysts in the cup bed using allogeneic cancellous bone and changing the prosthetic head.No further information.

Manufacturer Narrative

H3: a number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk factors specified in the hhe.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 ; 3523782617
• MDR Report Key: 18843150
• MDR Text Key: 336957431
• Report Number: 1038671-2024-00403
• 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: 03/05/2024

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: 09/08/2019
• 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
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/05/2024
• Date Device Manufactured: 09/10/2014
• 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: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female