MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 VELYS HIP NAV TOWER SOFTWARE; SOFTWARE AS A MEDICAL DEVICE

Model Number	451580051
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Please note that a physical manufacturer in section g of this report was not provided as this is a software as a medical device product.This software is sold and distributed as a stand alone software and is not associated with hardware.The reason for non-evaluation was marked as other due to reported product is software.An investigation was performed by interview.Investigation summary: an investigation confirmed the reported event.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.
Event or Problem Description
It was reported that the issue: one trial analysis chart does not correctly reflect the change to leg length when changing between proximal body heights.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: an investigation confirmed the reported event.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.

• Brand Name: VELYS HIP NAV TOWER SOFTWARE
• Common Device Name: SOFTWARE AS A MEDICAL DEVICE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10655439
• Report Number: 1818910-2020-21837
• Device Sequence Number: 3907558
• Product Code: LLZ
• UDI-Device Identifier: 10603295522850
• UDI-Public: 10603295522850
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K160284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 451580051
• Device Catalogue Number: 451580051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown