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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE FEMORAL RESURFACING HEAD 44MM; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE FEMORAL RESURFACING HEAD 44MM; HIP COMPONENT Back to Search Results
Model Number 38031044
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to unexplained pain|.Adverse soft tissue reaction to particulate debris.Revision njr number: (b)(4).Side:l.Primary asa: p1 - fit and healthy.Component not revised: conserve® thin shell ha coated 44mm id 50mm od beaded product id: 38ha4450 lot no.: 125283320.Mhra reference no: (b)(4).
 
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Brand Name
CONSERVE FEMORAL RESURFACING HEAD 44MM
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 Key11776297
MDR Text Key249035904
Report Number3010536692-2021-00276
Device Sequence Number1
Product Code KXA
UDI-Device IdentifierM684380310441
UDI-PublicM684380310441
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 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number38031044
Device Catalogue Number38031044
Device Lot Number037416781
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/22/2021
Date Manufacturer Received04/22/2021
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;
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