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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 36MM HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 36MM HIP COMPONENT Back to Search Results
Model Number 38AC-3600
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once the investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly, patient revised due to recurrent dislocations, pseudotumor and elevated metal ions.
 
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Brand NameCONSERVE® TOTAL A-CLASS® 36MM
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 Key8335127
MDR Text Key136007839
Report Number3010536692-2019-00391
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number38AC-3600
Device Catalogue Number38AC-3600
Device Lot Number1476496
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/28/2018
Event Location No Information
Date Manufacturer Received08/28/2018
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: 02/13/2019 Patient Sequence Number: 1
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