MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR(R) G26 BIPOLAR; HIP COMPONENT

Catalog Number GLJG-2647

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

Allegedly the surgeon performed bha surgery on (b)(6) 2016.The surgeon performed re-surgery on the same day to remove tissue at airspace between cup and acetabular because he confirmed airspace after surgery.The surgeon removed the cup, neck and head to remove tissue.On (b)(6) the patient had pain at surgery portion when he woke up at his home.He didn't tip over.And the surgeon confirmed dissociation.So the surgeon performed re-surgery to change cup, neck and head.The parts are not consignment parts.We will return just cup, neck and head.

• Brand Name: GLADIATOR(R) G26 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: 6256317
• MDR Text Key: 64935058
• Report Number: 3010536692-2017-00023
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: GLJG-2647
• Device Lot Number: 1615899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/05/2017
• Date Manufacturer Received: 01/05/2016
• 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: 87 YR