MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US VELYS HIP NAV TOWER SOFTWARE; VELYS HIP TOWER SOFTWARE

Model Number 451580051

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary an investigation was able to confirm the complaint.The incident was raised to r&d.This issue has been repaired with an update of s-rom implant template data in the databases associated with all active servers supporting velys hip navigation.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The metadata corresponding to the leg length and offset for the s-rom stem family isn't displayed correctly in the production environment.There are also discrepancies in the metadata that cause the center of rotation for the femoral head to be placed in the the incorrect location.This was found by the r&d team and a software update is planned for (b)(6) 2022.

• Brand Name: VELYS HIP NAV TOWER SOFTWARE
• Type of Device: VELYS HIP TOWER SOFTWARE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15616404
• MDR Text Key: 306335940
• Report Number: 1818910-2022-20598
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 10603295522850
• UDI-Public: 10603295522850
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 451580051
• Device Catalogue Number: 451580051
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1