MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	136-36-52
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomittants: 100-28-00 - cocr femoral head 28mm +0mm neck 114-11-02 - acumatch p series porous coated 120-01-50 - acumatch cluster cup porous coated 50mm 132-28-06 - acumatch 15 degree liner 136-36-52 - nv gxl lnr, +5lat, 36mm g2-52/54mm cups 170-36-93 - biolox delta femoral head 36mm od, -3.5mm 180-65-20 - alteon 6.5mm screw, 20mm 190-31-03 - alt ha s clr ext sz 3.
Event or Problem Description
It was reported that a female patient, initial right hip implanted on an unknown date, underwent a revision procedure in (b)(6) 2024.The cup was revised to a competitor¿s device and the femoral head balls were revised due to pain.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted devices are not available for return.Reason unknown.Device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, g4, h6 mdr section codes updated/corrected: a, b, c, d, g the most likely cause for the revision reported due to early prosthesis wear/osteolysis is 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).The prosthesis wear/osteolysis was able to be confirmed from the provided radiograph.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 G2-52/54MM 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 ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21029671
• Report Number: 1038671-2024-05034
• Device Sequence Number: 9155927
• Product Code: JDI
• UDI-Device Identifier: 10885862038784
• UDI-Public: 10885862038784
• 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 Explanted Year: 2024
• 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
• Report Date (Section B): 09/25/2025

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 Catalogue Number: 136-36-52
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 09/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female