MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FINAL IMPACTOR; HIP INSTRUMENT

Model Number APA09028

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly deformation of the tip.Surgery was extended greater than 30 minutes.Kit number: prglkit4; kit lot number: g180963.

• Brand Name: FINAL 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: 8903127
• MDR Text Key: 154630430
• Report Number: 3010536692-2019-00999
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: M684APA090281
• UDI-Public: M684APA090281
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APA09028
• Device Catalogue Number: APA09028
• Device Lot Number: CN151526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2019
• Date Manufacturer Received: 07/18/2019
• 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