MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY(R) SHELL IMPACTOR; HIP INSTRUMENT

Catalog Number 3333-0010

Device Problems Difficult to Remove (1528); Device Issue (2379)

Patient Problem No Information (3190)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

This is the same event as 3010536692-2016-00466.This report will be updated when investigation is complete.Trends will be evaluated.

Event Description

During the surgery, once the surgeon impacted the cup he couldn't unscrew the impactor anymore.

• Brand Name: DYNASTY(R) SHELL IMPACTOR
• Type of Device: HIP INSTRUMENT
• 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: 5574109
• MDR Text Key: 42554464
• Report Number: 3010536692-2016-00465
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 3333-0010
• Device Lot Number: 1147729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/31/2016
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention