MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant devices.Biolox delta femoral head 32mm od, +0mm (cat# 170-32-00 / serial# (b)(6) integrip cc, cluster 48mm, g1 (cat# 186-01-48 / serial# (b)(6) wedge plasma x/o sz 9 (cat# 188-01-09 / serial# (b)(6) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that this 68 y/o female patient's right hip was revised from a gxl liner to an xle liner and a biolox head and sleeve.Due to lysis recall.The patient was revised to a competitor's liner and a + 32 biolox head +3.5 sleeve.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation due to the patient wants to keep the device.
Additional Manufacturer Narrative
Correction: h6 medical device problem code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, g.The most likely underlying cause for the revision reported is fracture, recalled polyethylene, and a combination of the risk factors: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, prosthesis wear could not be confirmed from the information provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: NV GXL LINER LIPPED 32MM 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
• MDR Report Key: 19641013
• Report Number: 1038671-2024-02212
• Device Sequence Number: 15227067
• Product Code: JDI
• UDI-Device Identifier: 10885862207029
• UDI-Public: 10885862207029
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2025

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: 08/03/2019
• Device Model Number: NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
• Device Catalogue Number: 132-32-51
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 10/30/2025
• Initial Report FDA Received Date: 06/30/2024
• Supplement Report FDA Received Date: 07/16/2024; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female