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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT Back to Search Results
Model Number 38AM-4804
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Allegedly, primary tha was performed on (b)(6) 2009. Revision surgery was performed by cup loosening on (b)(6) 2018. During revision surgery, the surgeon was not able to remove the neck from the stem so he revised just the cup and head on (b)(6). And he performed re-revision surgery to remove the stem and the neck on (b)(6). The surgeon believes that the neck-stem junction was cold welding. Please dissociate them and investigate each surface condition for the neck and stem tapers by sem. We have been required the investigation by taking sem on the tapers. We will return just the neck and the stem. The parts are not consignment parts. (related to incident (b)(4)).
 
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Brand NameCONSERVE(R) 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 Key7485131
MDR Text Key107310441
Report Number3010536692-2018-00584
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
PMA/PMN Number
K051348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AM-4804
Device Catalogue Number38AM-4804
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/02/2018
Event Location No Information
Date Manufacturer Received05/02/2018
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: 05/03/2018 Patient Sequence Number: 1
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