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

Model Number PRTLS025

Device Problem Collapse (1099)

Patient Problem No Information (3190)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event 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
• Type of Device: HIP 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: 10114304
• MDR Text Key: 193628769
• Report Number: 3010536692-2020-00384
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PRTLS0251
• UDI-Public: M684PRTLS0251
• Combination Product (y/n): N
• PMA/PMN Number: K123688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: PRTLS025
• Device Catalogue Number: PRTLS025
• Device Lot Number: 1701026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2020
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 100 YR