MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. STELKAST HIP ARTHROPLASTY; PROVIDENT HIP STEM, LATERAL, 10MM

Model Number SC2658-10.0

Device Problem Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

It was reported that a revision was needed to replace a stelkast hip implant that failed post operatively.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device could not be provided for evaluation.The imaging provided shows the femoral head center of rotation appears to shift laterally.No determinations could be made as to the cause of the reported issue.

• Brand Name: STELKAST HIP ARTHROPLASTY
• Type of Device: PROVIDENT HIP STEM, LATERAL, 10MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18834167
• MDR Text Key: 337434319
• Report Number: 3004142400-2023-00051
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10840843107170
• UDI-Public: 10840843107170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC2658-10.0
• Device Lot Number: 42711
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other