MAUDE Adverse Event Report:; HIP, STEM, CLP, STANDARD, SIZE#4, IMPLANT, POLISHED NECK

Catalog Number 426-10-040

Device Problems Loose or Intermittent Connection (1371); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Corrected data: original initial report was submitted as follow up in error.

Event Description

Revision surgery - due to the patient's hip being slightly loose.The surgeon undersized the fumar component.

• Type of Device: HIP, STEM, CLP, STANDARD, SIZE#4, IMPLANT, POLISHED NECK
• MDR Report Key: 10686967
• MDR Text Key: 211637886
• Report Number: 1644408-2016-00491
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/08/2020

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
• Device Operator: No Information
• Device Catalogue Number: 426-10-040
• Device Lot Number: 404N1001
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention