MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR TL CLASSIC STEM SIZE 5 STRAIGHT SHORT NE; HIP COMPONENT

Model Number	PRTLS025
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, bone cracks occurred in the middle of the insertion position.Intraoperative radiography showed a spiral fracture occurred in the middle of the stem insertion position.(b)(4).

• Brand Name: PROFEMUR TL CLASSIC STEM SIZE 5 STRAIGHT SHORT NE
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10114304
• Report Number: 3010536692-2020-00384
• Device Sequence Number: 11668265
• Product Code: JDI
• UDI-Device Identifier: M684PRTLS0251
• UDI-Public: M684PRTLS0251
• Combination Product (Y/N): N
• PMA/510(K) Number: K123688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: Other
• Device Model Number: PRTLS025
• Device Catalogue Number: PRTLS025
• Device Lot Number: 1701026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 08/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention