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 Osteolysis (2377)

Event Date 01/25/2024

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 an approximately 67 yo male patient, initial hip implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2024, approximately 4 years 1 month post the initial procedure.As part of the manufacturer's recall campaign, the patient came in to have the right hip prosthesis that was implanted in 2019 checked.X-ray control showed a clear decentering of the prosthesis head and unusually large osteolysis in the acetabulum as signs of inlay wear.This was verified when the inlay was changed on (b)(6) 2024, to a vitd-hardened, specially approved inlay (novation xle, neutral liner, group 2, 36 mm i.D., ref (b)(4), sn (b)(6).As part of the replacement operation, in addition to the inlay replacement, the firm socket integrity was determined as well as the curettage and sealing of the cysts in the socket using allogeneic cancellous bone and the replacement of the prosthetic head.Diagnosis that led to the implantation: primary coxarthrosis m16.1 implanting clinic: bwkrhs westerstede item data for the implantation and replacement, as well as photos of the explants, will be submitted after receipt of a confirmation of receipt with bfarm case number.The explants are currently in the (b)(6) for microbiological examination using sonication.After the examination has been completed (14 days of long-term incubation), these are sent back to us and then - provided the patient has given their consent - made available to the manufacturer upon request for further material-technical examination.Surgical reports/x-rays are also available upon request.No further information.

Manufacturer Narrative

H3: the most likely cause for the revision reported due to early prosthesis wear is a combination of the risk factors specified, "including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential)".However, prosthesis wear cannot be confirmed as neither radiographs nor the devices were 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: 18758331
• MDR Text Key: 336000985
• Report Number: 1038671-2024-00290
• 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,Followup
• Report Date: 04/15/2024

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: 04/18/2024
• Device Model Number: NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
• Device Catalogue Number: 130-32-52
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/15/2024
• Date Device Manufactured: 04/18/2019
• 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: 67 YR
• Patient Sex: Male