MAUDE Adverse Event Report:; SLEEVE, UNIPOLAR, OFFSET -3.5

Catalog Number 411-00-035

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Original initial report was submitted as follow up in error.

Event Description

Revision surgery - due to the patient's hip dislocating.The surgeon removed and exchanged out the sleeve.

• Type of Device: SLEEVE, UNIPOLAR, OFFSET -3.5
• MDR Report Key: 11823623
• MDR Text Key: 250711609
• Report Number: 1644408-2017-00884
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 411-00-035
• Device Lot Number: 903B1977
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention