• 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. EVOLUTION(TM) MP FEMORAL COMPONENT; KNEE 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. EVOLUTION(TM) MP FEMORAL COMPONENT; KNEE COMPONENT Back to Search Results
Model Number EFSR-N5PR
Device Problem Insufficient Information (3190)
Patient Problem Neck Stiffness (2434)
Event Date 11/09/2016
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly, patient suffering from flexion contracture of her knee.Additional information received 01/12/2018.Upon first follow-up post-op, subject was described as "v.Stiff".Subject was given a cylindrical cast on (b)(6) 2016.Cast was removed on (b)(6) 2016.Subject as given jas brace.Subject was given botox injections.Subject has one rigorous physiotherapy.Upon follow-up on (b)(6) 2017, surgeon recommended r knee scope and lysis of scar tissue.
 
Manufacturer Narrative
Updated incident description and explant date.
 
Event Description
(b)(4).Allegedly the patient is suffering from flexion contracture of the knee.(b)(4).Additional information received on 10/26/2017: allegedly the patient underwent surgery of the knee, including arthroscopy, extensive synovectomy, quadriceplasty, and manipulation under anesthesia.On april 24, 2017.Patient was also tested for allergens (b)(4).Additional information received on 04/03/2018: allegedly the patient was revised due to flexion contracture and allergic reaction to metals on (b)(6) 2017.Tibial component was retained.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVOLUTION(TM) MP FEMORAL COMPONENT
Type of Device
KNEE 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 Key7259183
MDR Text Key99589018
Report Number3010536692-2018-00101
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/12/2018
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 NumberEFSR-N5PR
Device Catalogue NumberEFSR-N5PR
Device Lot Number1659993
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/12/2018
Initial Date Manufacturer Received 01/12/2018
Initial Date FDA Received02/09/2018
Supplement Dates Manufacturer Received01/12/2018
01/12/2018
Supplement Dates FDA Received03/15/2018
07/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
Patient Weight58
-
-