MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR® G26 BIPOLAR 41MM; KNEE COMPONENT

Lot Number 1686932

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 03/10/2017

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) 2017.The patient fell to the ground on (b)(6) and she had dissociation.We don't know how she fell on the ground because nobody had seen it.So the surgeon performed a revision surgery on (b)(6) 2017.The surgeon suspects the mechanical strength (pull out/level out) is weaker than perfecta bipolar cup or competitor's one.

• Brand Name: GLADIATOR® G26 BIPOLAR 41MM
• Type of Device: KNEE 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: 6432583
• MDR Text Key: 70812477
• Report Number: 3010536692-2017-00437
• 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: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 1686932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/17/2017
• Date Manufacturer Received: 03/17/2017
• 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: 84 YR