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

Model Number	NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Insufficient Information (4580)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As part of the manufacturer's recall campaign, the patient presented himself for a check-up of the device implanted in 2018 hip prosthesis.The x-ray control showed a clear decentering of the prosthetic base and unusually large osteolysis in the acetabulum as a sign of premature inlay wear.This could happen.Revision can be verified with cup replacement (mrs titan max 56 mm).As part of the replacement operation.The curettage and filling of the cysts in the acetabulum was carried out using allogeneic spongiosa and the replacement of the cysts prosthetic head.Item data of the implantation and replacement, as well as photos of the explants, will be sent upon receipt.The explants are currently in the laboratory doctor's office for microbiological examination using sonication.After the examination (14 days of long-term incubation), these will be sent back to the customer and will be made available if the customer provides consent.No further information.
Additional Manufacturer Narrative
D10: concomitant: 5326420 180-01-52 - crown cup,cluster-hole gr.52.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: implanted with a lateralized liner and implanted with a component having a shelf age of greater than 2 years.The revision reported was likely the result of a combination of both patient-related conditions and the risk factors specified.In 2022 all gxl were removed from the market under recall # 18832/21.However, this cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.

• Brand Name: NOVATION
• Common Device Name: 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 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17958726
• Report Number: 1038671-2023-02557
• Device Sequence Number: 15214943
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS
• Device Catalogue Number: 136-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 01/16/2024; 09/22/2026
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 02/14/2024; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female