MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR R PROXIMAL BODY; HIP COMPONENT

Model Number PPWX-XXXX

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

Per abstract by bellotti et al.From the 11th european hip society congress (october 2014), titled "the italian-spanish experience with cementless modular revision stem: outcome of 139 hip after an average of 5 years follow-up.": allegedly 2 patients required a revision for a stem subsidence.The authors noted that in both cases the stem was under-dimensioned.No further information was provided regarding these adverse events.Microport is unable to determine if the event occurred in (b)(6).

• Brand Name: PROFEMUR R PROXIMAL BODY
• 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: 7406811
• MDR Text Key: 104683906
• Report Number: 3010536692-2018-00408
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

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: PPWX-XXXX
• Device Catalogue Number: PPWX-XXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2018
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 11/30/2018
• 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