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

Model Number	NV GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 170-40-93/biolox delta femoral head 40mm od, -3.5mm; 180-65-20/alteon 6.5mm screw, 20mm; 186-01-56/nv crown cup clstr hole 56mm group 3; 190-30-03/alt ha s clr std sz 3.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a male patient, initial right hip implanted on an unknown date, underwent a revision procedure on (b)(6) 2023, reason for the revision was not reported.The patient¿s gxl liner and cup were revised to competitor¿s devices with exactech ceramic heads and sleeves.The event was not related to a breakage of a device.There were no surgical delays.The patient was last known to be in stable condition following the event.Device images and x-rays were provided.The devices are not available for return as they were sent to pathology.No patient information, history, or comorbidities reported.No further information.
Additional Manufacturer Narrative
H3: the nv gxl lnr device information was not reported.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.The patient has bilateral hip replacements.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following corrections have been made: b1, b2, b5, d1, d4 (remove expiration date from initial), d8, g1, h4 (remove manufactured date from initial)), h6: medical device code, component code, types of investigation, investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that a male patient, initial right hip implanted on an unknown date, underwent a revision procedure.The reason for the revision was not reported.The patient¿s gxl liner and cup were revised to competitor¿s devices with exactech ceramic heads and sleeves.The event was not related to a breakage of a device.There were no surgical delays.The patient was last known to be in stable condition following the event.Device images and x-rays were provided.The devices are not available for return as they were sent to pathology.No patient information, history, or comorbidities reported.No further information.

• Brand Name: UNKNOWN HIP COMPONENT
• 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 ; 3523771140
• MDR Report Key: 16756214
• Report Number: 1038671-2023-00708
• Device Sequence Number: 8528365
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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 Model Number: NV GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 02/06/2026
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 12/18/2023; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male