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
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 investigation conclusion.The most likely cause for the revision reported due to early prosthesis wear/osteolysis is a combination of the risk 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 because the device was not returned for evaluation and images or radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18758574
• Report Number: 1038671-2024-00292
• Device Sequence Number: 6271340
• Product Code: JDI
• UDI-Device Identifier: 10885862022172
• UDI-Public: 10885862022172
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 04/30/2024; 11/13/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 05/02/2024; 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Unknown