MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL NTRL LNR G2 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	140-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10.H10.Pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.Serial number not confirmed.Item number and full description serial number 140-36-52 - nv ehxl ntrl lnr g2 36mm, (b)(6).140-36-52 - nv ehxl ntrl lnr g2 36mm, (b)(6).Concomitants: 170-36-50 - biolox delta option femoral head 36mm od 6840729.170-50-03 - biolox delta adapter 16/18-12/14; +3.5mm 7219723.180-65-25 - alteon 6.5mm screw, 25mm s349309.
Event or Problem Description
It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2022 and then experienced a revision surgical procedure on (b)(6) 2022 approximately 2 months after initial implant.No other patient information / medical history reported.No images of the devices are provided.The device will not be returned.There is no other information available.

• Brand Name: NV EHXL NTRL LNR G2 36MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19011057
• Report Number: 1038671-2024-00701
• Device Sequence Number: 3809546
• Product Code: LZO
• UDI-Device Identifier: 10885862537317
• UDI-Public: 10885862537317
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 140-36-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 04/01/2024
• 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
• Patient Sex: Unknown