MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Insufficient Information (4580); Aseptic loosening (4883)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomittants: 170-36-93/ biolox delta femoral head 36mm od, -3.5mm 180-65-20/ alteon 6.5mm screw, 20mm 180-01-56/ nv crown cup clstr hole 56mm group 3 190-30-05/ alt ha s clr std sz 5.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 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 and exactech's ceramic head/sleeve.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: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.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, d1, d4(remove all from initial report-suspect device unknown), g2, g4 (remove 501k from initial report-unknown), h6 medical device code, component code, types of investigation, investigation conclusions.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 the patient underwent an initial total hip replacement on the right side.Subsequently, the patient experienced pain, discomfort, osteolysis and aseptic loosening secondary to prosthesis wear.As a result, approximately four years post-surgery, the patient underwent a revision.It was noted the patient had dense scar tissue.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available.This is report 1 of 3 for this event/patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.D10: 180-65-20 - alteon 6.5mm screw, 20mm: sn# (b)(6), 180-65-20 - alteon 6.5mm screw, 20mm: sn# (b)(6), 186-01-56 - integrip cc, cluster 56mm, g3: sn# (b)(6), 190-30-05 - alt ha s clr std sz 5: sn# (b)(6), 170-36-93 - biolox delta femoral head 36mm od, -3.5mm: sn# (b)(6).The following sections were corrected: b4, d1, d4, d6a, d10, g3, g4, h4, h6 - health effect, medial device problem, component code, type of investigation, investigation findings, investigation conclusions.The revision reported was likely the result of prosthesis wear of the polyethylene liner and loosening of the bone screws.The reported screw loosening cannot be confirmed but may be related to inadequate initial fixation, mechanical loss of fixation over time, or biologic loss of fixation caused by particle-induced osteolysis around the implant.However, this cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and initial post-operative 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: NV GXL LNR, +5LAT, 36MM G3-56/58MM 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: kate jacobson ; 3523771140
• MDR Report Key: 16753856
• Report Number: 1038671-2023-00706
• Device Sequence Number: 20976494
• Product Code: JDI
• UDI-Device Identifier: 10885862024336
• UDI-Public: 10885862024336
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/30/2026

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: 06/25/2019
• Device Model Number: NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
• Device Catalogue Number: 136-36-53
• 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: 11/29/2023; 02/11/2026; 03/27/2026
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 12/18/2023; 03/02/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown