MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMURR; HIP COMPONENT

Model Number PPW3XXXX

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

The complaint will be updated once the investigation is completed.Trends will be evaluated.

Event Description

Allegedly, per paper by de meo et al.From the 2018 acta ortopaedica italica, titled "modular stem in hip dysplasia crowe iii e iv: mid-term clinical and radiological outcomes.": allegedly 1 patient had a periprosthetic fracture after 32 months of implantation, stem was not revised, patient was treated with cerclage wires.Patients in this cohort were primary cases with severe hip dysplasia.No further information was provided regarding these adverse events.

• Brand Name: PROFEMURR
• 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: 8651793
• MDR Text Key: 146423857
• Report Number: 3010536692-2019-00779
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PPW3XXXX
• Device Catalogue Number: PPW3XXXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/10/2019
• Date Manufacturer Received: 05/10/2019
• 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