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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 52MM HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 52MM HIP COMPONENT Back to Search Results
Model Number 38AC-5200
Device Problem Insufficient Information (3190)
Patient Problem Reaction (2414)
Event Type  Injury  
Event Description
Allegedly the patient has what appears to be a mal-positioned cup. Dr. (b)(6) is aware that this ti neck should be removed. (right). Head, sleeve, neck and cup was removed. Stryker cup was implanted with screws and their dual mobility liner was used with our head(28mm) and neck. Cultures taken.
 
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Brand NameCONSERVE® TOTAL A-CLASS® 52MM
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 Key7971366
MDR Text Key123899003
Report Number3010536692-2018-01312
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
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AC-5200
Device Catalogue Number38AC-5200
Device Lot Number079901194
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/10/2018
Event Location No Information
Date Manufacturer Received10/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/16/2018 Patient Sequence Number: 1
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