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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL A-CLASS HEAD HIP COMPONENT Back to Search Results
Model Number 38AM5635
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem Metal Related Pathology (4530)
Event Date 09/07/2019
Event Type  Injury  
Manufacturer Narrative
This event was initially reported under 3010536692-2019-01083. This is an additional component associated to the event according the new information provided.
 
Event Description
Allegedly, patient was revised for a broken neck. Additional information received on 02/05/2021: allegedly, on the revision surgery dr. (b)(6) also found a pseudo-tumor.
 
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Brand NameCONSERVE TOTAL A-CLASS HEAD
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 Key11342086
MDR Text Key232327108
Report Number3010536692-2021-00083
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 other
Reporter Occupation
Type of Report Initial
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AM5635
Device Catalogue Number38AM5635
Device Lot Number046334711
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/05/2021
Event Location No Information
Date Manufacturer Received02/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/18/2021 Patient Sequence Number: 1
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