MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	NV EHXL ALIP LNR G2 36MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Implant Pain (4561); Medical device site infection (4845)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: cocr fem head 36mm -3.5 offset 12/14 (cat# 142-36-93 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 3 years post initial tha, the 80 y/o male patient had a revision needed due to chronic infection.The patient was seen for pain and swelling last week with drainage.Patient had liner and head removed and arthrotomy and irrigation with debridement done.A new exactech liner and head implanted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was not unable to obtain photos/x-rays.The devices are not available for evaluation due infect hip implants.
Additional Manufacturer Narrative
The reason for the reported surgical intervention due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical risk, as outlined in the ifu.D1: corrected.D4/d6: device, serial #, udi #, expiration, implant and explant dates unknown.D10 concomitants: (b)(6) - 42-36-93 - cocr fem head 36mm -3.5 offset 12/14.(b)(6) - 160-10-14 - pf stem taper plasma h/a sz 14.(b)(6) - 180-01-52 - nv crown cup clstr hole 52mm group 2.(b)(6) - 180-65-15 - alteon 6.5mm screw, 15mm.(b)(6) - 180-65-20 - alteon 6.5mm screw, 20mm.G3: manufactured dates unknown.G4: pma 510k cannot be determined.H6: corrected health effect, component and investigation clinical codes.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653
• MDR Report Key: 19355844
• Report Number: 1038671-2024-01356
• Device Sequence Number: 3770025
• Product Code: LZO
• UDI-Device Identifier: 10885862537638
• UDI-Public: 10885862537638
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: 09/20/2025
• Device Model Number: NV EHXL ALIP LNR G2 36MM
• Device Catalogue Number: 142-36-62
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2020
• 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: ALTEON 6.5MM SCREW, 15MM; ALTEON 6.5MM SCREW, 20MM; COCR FEM HEAD 36MM -3.5 OFFSET 12/14; NV CROWN CUP CLSTR HOLE 52MM GROUP 2; PF STEM TAPER PLASMA H/A SZ 14
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male