MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G3 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	140-36-53
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Discomfort (2330); Ambulation or Postural Difficulties (2544)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: (6024196) 190-30-05 - alt ha s clr std sz 5.(6085163) 170-36-00 - biolox delta femoral head 36mm od, +0mm, (5620379)186-01-56 - integrip cc, cluster 56mm, g3.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 45 months after a total hip replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, discomfort and difficulty walking.Patient has suffered injuries due to poly wear and device failure.No operative reports were included.No further issues or complications were reported.No additional information is available.".
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of femoral loosening, stem subsidence/migration, and prosthesis wear of the liner.However, this cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.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 G3 36MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19837714
• Report Number: 1038671-2024-02557
• Device Sequence Number: 6768715
• Product Code: JDI
• UDI-Device Identifier: 10885862537324
• UDI-Public: 10885862537324
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 02/19/2024
• Device Catalogue Number: 140-36-53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2019
• 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 H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown