MAUDE Adverse Event Report: EXACTECH, INC. Novation Hip Component; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

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	Inflammation (1932); Fluid Discharge (2686)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: serial #: (b)(4), catalog #: 170-36-03 - biolox delta femoral head 36mm od, +3.5mm, serial #: (b)(4), catalog #: 180-65-45 - alteon 6.5mm screw, 45mm.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision was determined to be due to the incision was draining.These devices are used for treatment not diagnosis.
Event or Problem Description
It was reported that a male patient, initial right hip revision implant date, (b)(6) 2022, underwent a second revision procedure on (b)(6) 2022, approximately 2 months post the prior procedure.His incision was draining.The male patient was brought back for an irrigation and debridement of the right hip.The hip was dislocated, the femoral head removed and attention turned to the cup.The liner was removed with the help of a bone screw.The hip was washed thoroughly and new xle group 2 lipped poly, 36+3.5 biolox head, and 10 cc of intersep were implanted.The patient was last known to be in stable condition following the event.The device will not be returned.The hospital discarded it.No further information.

• Brand Name: Novation Hip Component
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16195618
• Report Number: 1038671-2023-00042
• Device Sequence Number: 5807279
• Product Code: JDI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2026

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 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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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: Male