MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G2 32MM; HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEME

Catalog Number	140-32-52
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined; however, may have resulted from wear, osteolysis, loosening, infection, fracture, instability/dislocation, leg length discrepancy, and/or patient related factors.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.
Event or Problem Description
It was reported that this patient underwent an initial hip replacement.Subsequently, the patient was revised for unknown reasons.No further information at this time.
Event or Problem Description
It was reported that the patient underwent an initial tha (total hip arthroplasty).Subsequently, the patient experienced an infection resulting in a revision of the head and liner.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: a3, d6b, d10.D10: 180-01-52 - crown cup,cluster-hole gr.52: sn #: (b)(6).140-32-52 - novation xle neutral liner, group 2, 32 mm: sn #: (b)(6).The following sections were corrected: b5, d1, h6.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were added/corrected: b3, d6a/d6b, h4, h6: type of investigation.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Infection is a known surgical risk, 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d2a, d2b, d4, g4, h6.

• Brand Name: NV EHXL NTRL LNR G2 32MM
• Common Device Name: HIP, SEMI-CONSTRAINED, CEMENTED, METAL/CERAMIC/POLYMER + ADDITIVE, POROUS UNCEME
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22913327
• Report Number: 1038671-2025-02856
• Device Sequence Number: 9221551
• Product Code: OQI
• UDI-Device Identifier: 10885862537270
• UDI-Public: 10885862537270
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/18/2026

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: 140-32-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 01/27/2026; 02/18/2026
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 12/05/2025; 02/17/2026; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2023
• 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: Hospitalization
• Patient Sex: Female