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

Model Number	PRPR0006
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	10/19/2021
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, 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.
Additional 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
• Common Device Name: 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
• Report Number: 3010536692-2021-00580
• Device Sequence Number: 1792811
• Product Code: JDL
• UDI-Device Identifier: M684PRPR00061
• UDI-Public: M684PRPR00061
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 85 KG