MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 11 V8D; HIP COMPONENT

Model Number PLLER011

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the surgeon has prepared the femur for a size 10 but the sales representative initially gave him a size 11, which did not seat fully but became stuck in the femur.An osteotomy had to be performed to remove this stem.

• Brand Name: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 11 V8D
• 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: 9904279
• MDR Text Key: 186298507
• Report Number: 3010536692-2020-00300
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PLLER0111
• UDI-Public: M684PLLER0111
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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: PLLER011
• Device Catalogue Number: PLLER011
• Device Lot Number: 1561104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR