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

Model Number	APA09028
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly deformation of the tip.Surgery was extended greater than 30 minutes.Kit number: prglkit4; kit lot number: g180963.

• Brand Name: FINAL IMPACTOR
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8903127
• Report Number: 3010536692-2019-00999
• Device Sequence Number: 243136
• Product Code: HWA
• UDI-Device Identifier: M684APA090281
• UDI-Public: M684APA090281
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: APA09028
• Device Catalogue Number: APA09028
• Device Lot Number: CN151526
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention