MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G1 32MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER,

Catalog Number	140-32-51
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374); Periprosthetic fracture (4902)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study, that the 69 yo female patient was experiencing dislocation, (i.E.Pain, infection).The patient dislocated anteriorly and periprosthetic fracture.The patient was revised on (b)(6) 2019.
Additional Manufacturer Narrative
D10.Concomitants: serial #: unassigned, category #: 32135-38h-17 - 17-4 flex drill m 3.2x38 lenkbar, serial #: (b)(4) , category #: 162-00-03 - neck preserving stem, std offset plasma sz 3, serial #: (b)(4) , category #: 162-00-03 - neck preserving stem, std offset plasma sz 3, serial #: (b)(4) ,category #: 170-32-00 - biolox delta femoral head 32mm od, +0mm, serial #: (b)(4) , category #: 170-32-00 - biolox delta femoral head 32mm od, +0mm, serial #: (b)(4) , category #: 180-65-20 - alteon 6.5mm screw, 20mm, serial #: (b)(4) , category #: 180-65-20 - alteon 6.5mm screw, 20mm, serial #: (b)(4) , category #: 180-65-20 - alteon 6.5mm screw, 20mm, serial #: (b)(4) , category #: 180-65-20 - alteon 6.5mm screw, 20mm, serial #: (b)(4) , category #: 186-01-50 - integrip cc, cluster 50mm, g1, serial #: (b)(4) , category #: 186-01-50 - integrip cc, cluster 50mm, g1.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported was likely due to a periprosthetic bone fracture and dislocation.The cause of the bone fracture cannot be conclusively determined but may be related to a patient condition, a traumatic event, and/or surgical techniques.However, this cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.The reason for the reported revision due to instability cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Periprosthetic fracture and dislocation are known risks, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV EHXL NTRL LNR G1 32MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16768902
• Report Number: 1038671-2023-00747
• Device Sequence Number: 6436860
• Product Code: MEH
• UDI-Device Identifier: 10885862537263
• UDI-Public: 10885862537263
• Combination Product (Y/N): N
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 03/09/2024
• Device Catalogue Number: 140-32-51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 63 KG