MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, LIPPED, 28MM ID, GROUP 1 CUPS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, patient is requiring a hip revision surgery.A special approval for import of a device was requested.No further details known at this time.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the cause of the patient¿s condition and revision surgery as related to the devices cannot be conclusively determined based on the available information.These devices are used for treatment, not diagnosis.

• Brand Name: NV GXL LNR, LIPPED, 28MM ID, GROUP 1 CUPS
• 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: geoff gannon ; 3525541928
• MDR Report Key: 18946225
• Report Number: 1038671-2024-00595
• Device Sequence Number: 12599886
• Product Code: JDI
• UDI-Device Identifier: 10885862023155
• UDI-Public: 10885862023155
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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 Model Number: NV GXL LNR, LIPPED, 28MM ID, GROUP 1 CUPS
• Device Catalogue Number: 132-28-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male