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)
Health Effect - Clinical Codes	Failure of Implant (1924); Ambulation or Postural Difficulties (2544); Implant Pain (4561)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 61 y/o male patient's left hip was revised approximately 3 years 7 months post op initial surgery.Poly used was recalled.Stem was revised to competitors device.Patient was last known to be in stable condition following the event.Devices are not returning, hospital does not release explanted implants.
Additional Manufacturer Narrative
Section d10: concomitant products 5168652 190-30-11 - alt ha s clr std sz 11 5396347 180-65-20 - alteon 6.5mm screw, 20mm 5705460 186-01-56 - integrip cc, cluster 56mm,g3 6095033 101-05-20 - 3.2mm drill bit 20mm 1pk 6178327 170-36-93 - biolox delta femoral head 36mm od, -3.5mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3) based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: significant edge loading of the femoral head on the acetabular liner, implanted with a lateralized liner, and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to early prosthesis wear is a combination of the risk factors specified in an hhe.The prosthesis wear was able to be confirmed from the provided radiographs and images of the explanted devices.*the following sections have corrected information: (h6) type of investigation, investigation findings, investigation conclusion.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis as specified in the hhe: significant edge loading of the femoral head on the acetabular liner, implanted with a lateralized liner, and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to early prosthesis wear is a combination of the risk factors specified i: 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 was able to be confirmed from the provided radiographs and images of the explanted devices.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: geoff gannon
• MDR Report Key: 19259674
• Report Number: 1038671-2024-01082
• Device Sequence Number: 2581883
• Product Code: JDI
• UDI-Device Identifier: 10885862024336
• UDI-Public: 10885862024336
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2019
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 08/13/2024; 01/13/2025
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/30/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1729-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male