MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR(R) BIPOLAR; HIP COMPONENT

Catalog Number GLBP-3651

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problems Dementia (1808); Fall (1848)

Event Date 12/09/2015

Event Type  Injury  

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2016-00032 and 00033.

Event Description

Allegedly, shell & head disassociated and dislocated; patient suffers from dementia.Suspected fall, but due to patient's condition unable to determine for sure.

• Brand Name: GLADIATOR(R) BIPOLAR
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 5372243
• MDR Text Key: 36198750
• Report Number: 3010536692-2016-00034
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: GLBP-3651
• Device Lot Number: 1567754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/09/2015
• Event Location: Hospital
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 104