MAUDE Adverse Event Report:; HEAD, FEMORAL, CERAMIC, BILOX DELTA, 44MM -4.0

Catalog Number 400-03-441

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

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 loosening of stem.The surgeon corrected the stem and replaced the head and liner.

• Type of Device: HEAD, FEMORAL, CERAMIC, BILOX DELTA, 44MM -4.0
• MDR Report Key: 11815377
• MDR Text Key: 250325081
• Report Number: 1644408-2017-00182
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 400-03-441
• Device Lot Number: 876B1038
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention