• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® RENAISSANCE® STEM HIP COMPONENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROPORT ORTHOPEDICS INC. PROFEMUR® RENAISSANCE® STEM HIP COMPONENT Back to Search Results
Model Number PLS0S414
Device Problems Break (1069); Naturally Worn (2988)
Patient Problems Pain (1994); Metal Related Pathology (4530)
Event Date 01/11/2022
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly, there was a fracture of the femoral neck on (b)(6), 2022. Px had revision surgery. Intraoperative findings included failure of the neck shaft junction of the prosthesis with resultant metallosis and wear of surrounding soft tissue. No revised: dspcgf56 dynasty® pc shell 56mm group f lot# 1549941.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROFEMUR® RENAISSANCE® STEM
Type of DeviceHIP 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 Key14144062
MDR Text Key289528568
Report Number3010536692-2022-00131
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPLS0S414
Device Catalogue NumberPLS0S414
Device Lot Number1520795
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/29/2022
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 04/19/2022 Patient Sequence Number: 1
-
-