MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 36MM ID GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	132-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: (b)(6): 170-36-93 - biolox delta femoral head 36mm od, -3.5mm, (b)(6): 186-01-54 - integrip cc, cluster 54mm, g2, (b)(6): 188-00-11 - wedge plasma s/o sz 11.
Event or Problem Description
As reported via legal documentation, a patient had right hip replacement surgery on (b)(6) 2016.They underwent right hip revision surgery on (b)(6) 2023, approximately 7 years 2 months post primary procedure.Reported event is not related to breakage of device, there was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays attached.There is no other patient demographic or medical history available.There is no device return.No additional information is available.
Additional Manufacturer Narrative
The most likely cause for the revision reported due to prosthesis wear is a combination of risk factors 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 not confirmed with the information provided; devices were not returned.There is no other information available.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d4 (udi) g2, h6: clinical code, component code, type of investigation, investigation findings.The most likely cause for the revision reported due to prosthesis wear is a combination of risk factors 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 not confirmed with the information provided; devices were not returned.There is no other information available.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 LINER LIPPED 36MM ID GROUP 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 18657675
• Report Number: 1038671-2024-00171
• Device Sequence Number: 12530603
• Product Code: LZO
• UDI-Device Identifier: 10885862207036
• UDI-Public: 10885862207036
• 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: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2025
• 2 Devices were Involved in the Event: 1 2

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: 08/14/2021
• Device Catalogue Number: 132-36-52
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 04/15/2024; 11/28/2025
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/16/2024; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2016
• 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-1732-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male