MAUDE Adverse Event Report:; HIP, STEM, CLP, STANDARD, SIZE#5, IMPLANT, POLISHED NECK

Catalog Number 426-10-050

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - due to the original stem subsiding.The original stem, unipolar, and sleeve were all removed.

• Type of Device: HIP, STEM, CLP, STANDARD, SIZE#5, IMPLANT, POLISHED NECK
• MDR Report Key: 11811778
• MDR Text Key: 250182539
• Report Number: 1644408-2016-00818
• 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: 10/29/2020

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: 426-10-050
• Device Lot Number: 405N1000
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention