MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
Medical Device Problem Codes	Naturally Worn (2988); Lack of Effect (4065)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Insufficient Information (4580)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) - 132-36-53 - nv gxl lnr, lipped, 36mm id, group 3 cups.(b)(6) - 170-36-00 - biolox delta femoral head 36mm od, +0mm.(b)(6) - 186-01-56 - integrip cc, cluster 56mm, g3.(b)(6) - 188-01-08 - wedge plasma x/o sz 8.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 68 yo male patient, initial right hip implanted on (b)(6), 2017, underwent a revision procedure on (b)(6), 2024, approximately 6 years 2 months post the initial procedure.The surgeon performed a head and liner exchange due to the premature wear of a novation gxl liner.He revised to an xle liner and biolox delta option adapter and head.There were no surgical delays or device breakages during the event.No x-rays were able to be obtained.The patient was last known to be in stable condition following the event.No device returns were available as they were sent to legal.No device images were able to be obtained.No further information.
Additional Manufacturer Narrative
Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear as specified, implanted with a component having a shelf age of greater than 2 years.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors specified.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The most likely underlying cause for the revision reported is prosthesis wear and loss of range of motion and a combination of 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, this cannot be confirmed from the reported information and the devices were not available for evaluation.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, LIPPED, 36MM ID, GROUP 3 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18602639
• Report Number: 1038671-2024-00136
• Device Sequence Number: 2821249
• Product Code: JDI
• UDI-Device Identifier: 10885862023421
• UDI-Public: 10885862023421
• 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: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• 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): 07/07/2025

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: 07/02/2018
• Device Model Number: NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS
• Device Catalogue Number: 132-36-53
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 07/03/2025
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 04/15/2024; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2013
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 96 KG