Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. CONSERVE FEMORAL RESURFACING HEAD 42MM; 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. CONSERVE FEMORAL RESURFACING HEAD 42MM; HIP COMPONENT Back to Search Results
Model Number 38031042
Device Problem Loss of Osseointegration (2408)
Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to aseptic loosening socket; aseptic loosening stem; lysis socket; lysis stem; pain; adverse soft tissue reaction to particle debris revision njr number: (b)(4).Side:r.Primary asa: p3 - incapacitating systemic disease.Mhra reference no: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONSERVE FEMORAL RESURFACING HEAD 42MM
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 Key11273433
MDR Text Key232328038
Report Number3010536692-2021-00058
Device Sequence Number1
Product Code KXA
UDI-Device IdentifierM684380310421
UDI-PublicM684380310421
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K944752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number38031042
Device Catalogue Number38031042
Device Lot Number1049337910
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/21/2021
Date Manufacturer Received01/21/2021
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;
-
-