MAUDE Adverse Event Report: EXACTECH, INC. NV EHXL ALIP LNR G2 36MM; SEE H10

Catalog Number	142-36-62
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B5.The patient has filed a short-form complaint in a coordinated action in alachua county with master case no.(b)(4) ca 002670.The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action were required ¿to undergo revision surgeries due to severe, pain, swelling, and instability¿ due to ¿wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.¿ because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of an exactech polyethylene device.D2b.Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented.D10.Concomitants: 180-65-45 -s040637 alteon 6.5mm screw, 45mm.170-36-00 - 6878469 biolox delta femoral head 36mm od, +0mm.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that the patient was revised to a novation gxl on (b)(6) 2021.The patient has not been revised.There is no other patient demographic or medical history available.There is no other information available.
Additional Manufacturer Narrative
H 11.Correction- the device reported is not a recalled device-(b)(6) nv ehxl alip lnr g2 36mm-there are no issues reported.

• Brand Name: NV EHXL ALIP LNR G2 36MM
• Common Device Name: SEE H10
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17808350
• Report Number: 1038671-2023-02361
• Device Sequence Number: 17815463
• Product Code: OQI
• UDI-Device Identifier: 10885862537638
• UDI-Public: 10885862537638
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: 08/05/2024
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown