MAUDE Adverse Event Report:; STEM, HIP,FH 480 SERIES SIZE9 PC

Catalog Number 480-01-090

Device Problem 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 an undersized stem.

• Type of Device: STEM, HIP,FH 480 SERIES SIZE9 PC
• MDR Report Key: 10817409
• MDR Text Key: 215531480
• Report Number: 1644408-2016-00984
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/06/2020

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: 480-01-090
• Device Lot Number: 577C1034
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention