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 Osteolysis (2377)

Event Date 01/25/2024

Event Type  Injury  

Event Description

It was reported that an approximately 59 yo patient, initial hip implanted on (b)(6) 2020, underwent a revision procedure on (b)(6) 2024, approximately 3 years 2 months post the initial procedure.As part of the manufacturer's recall campaign, the patient presented to have the hip prosthesis implanted in 2020 checked.X-ray control showed a slight decentering of the prosthesis head and small 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 3, 36 mm i.D., ref 140-36-53, sn (b)(6).As part of the replacement operation, in addition to the inlay replacement, the solid integrity of the socket was determined as well as the curettage of the small cysts in the socket and the replacement of the prosthetic head.Diagnosis that led to 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 osnabrück laboratory doctor's office (rostocker str.5-7, 49124 georgsmarienhütte, tel.: 05401-33910) 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.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

H3: 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 because the device was not returned for evaluation and images or radiographs were not provided.

• 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: 18758574
• MDR Text Key: 336002732
• Report Number: 1038671-2024-00292
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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 Model Number: NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS
• Device Catalogue Number: 130-32-53
• 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: 04/30/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2020
• 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: 59 YR