MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; NV CROWN CUP CLSTR HOLE 52MM GROUP 2

Model Number	180-01-52
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.No information provided in the following section(s).
Event or Problem Description
As reported by the exactech hip replacement study, during the femoral preparation a calcar fracture was identified, and a protective cerclage was used.The event is not related to the device but related to the procedure.This event was received from the hip clinical study data.
Additional Manufacturer Narrative
The evaluation noted that the calcar fracture was reported to have occurred during the original surgery.Since the calcar was fractured during the original surgery, it likely occurred while preparing the femur and may have been related to the feed rate/pressure of the calcar planer, reamer rotational speed, or the patient¿s bone quality/geometry.

• Brand Name: NOVATION
• Common Device Name: NV CROWN CUP CLSTR HOLE 52MM GROUP 2
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9699856
• Report Number: 1038671-2020-00068
• Device Sequence Number: 16833219
• Product Code: JDI
• UDI-Device Identifier: 10885862037015
• UDI-Public: 10885862037015
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: 180-01-52
• Device Catalogue Number: 180-01-52
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 70