MAUDE Adverse Event Report:; LINER, METAL-METAL 28XMP9

Catalog Number 499-28-009

Device Problems Break (1069); 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 another company's stem breaking.The surgeon had to remove the stem and femoral head.Since the liner was disrupted by the surgery he replaced it with a standard e-poly.No wear was noted on the liner.

• Type of Device: LINER, METAL-METAL 28XMP9
• MDR Report Key: 11815388
• MDR Text Key: 250325381
• Report Number: 1644408-2017-00179
• Device Sequence Number: 1
• Product Code: KWA
• 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: 499-28-009
• Device Lot Number: 900611
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention