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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL A-CLASS 44MM FEMORAL HEAD; HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL A-CLASS 44MM FEMORAL HEAD; HIP COMPONENT Back to Search Results
Model Number 38AC4400
Device Problem Mechanical Problem (1384)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
Event was reported under number 3010536692-2020-00693.This is an additional component associated to the event.
 
Event Description
Allegedly, the neck sleeve and head came out as one during explant surgery and neck trunnion was black.Left hip.Head and necks were replaced.Components not revised: conserve® plus cup product number 38024450 lot number 029783710.Profemur® plasma z stem product number pha00262 lot number 049943762.
 
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Brand Name
CONSERVE TOTAL A-CLASS 44MM FEMORAL HEAD
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 Key11095357
MDR Text Key224395661
Report Number3010536692-2020-00795
Device Sequence Number1
Product Code JDL
UDI-Device IdentifierM68438AC44001
UDI-PublicM68438AC44001
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number38AC4400
Device Catalogue Number38AC4400
Device Lot Number048578403
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/15/2020
Date Manufacturer Received10/15/2020
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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