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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-460X
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Pain (1994); Reaction (2414)
Event Date 10/05/2010
Event Type  Injury  
Event Description
Orig. Surg. (b)(6) 2007, (b)(6), moderate activity level. Allegedly the cup was loose. Revised due to hip pain. Additional information received 05/09/2018 from wright medical litigation. Implant and explant dates.
 
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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 Key7551086
MDR Text Key109480372
Report Number3010536692-2018-00727
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AM-460X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2010
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/09/2018
Event Location No Information
Date Manufacturer Received05/09/2018
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: 05/29/2018 Patient Sequence Number: 1
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