MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® PRESERVE STEM SIZE 6; HIP COMPONENT

Model Number PRPR0006

Device Problem Fracture (1260)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient experienced a sudden onset of pain in the hip joint with subsequent buckling of the leg during normal walking the previous day.Radiological examination revealed a cone fracture.

Manufacturer Narrative

Due to additional information received from microport orthopedics reliability engineer and further analysis, it's considered that the product listed on this report as productid: prpr0006 profemur preserve stem , lot no: 1553951 ; should be changed to "no complaint stated" since there's no complaint against this device.Please void this report.

• Brand Name: PROFEMUR® PRESERVE STEM SIZE 6
• 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: 12957517
• MDR Text Key: 281901819
• Report Number: 3010536692-2021-00580
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PRPR00061
• UDI-Public: M684PRPR00061
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PRPR0006
• Device Catalogue Number: PRPR0006
• Device Lot Number: 1553951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2021
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 85 KG