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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 42MM HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 42MM HIP COMPONENT Back to Search Results
Model Number 38AC-4200
Device Problem Insufficient Information (3190)
Patient Problem Reaction (2414)
Event Date 01/01/2012
Event Type  Injury  
Event Description
Allegedly the patient began having some pain in left hip in 2012. Work up was negative. Symptoms progressed and became much worst in 2018. Work up last shown no evidence of loosening, osteolysis, infection or subsidence. However, co and cr ions are extremely high. We are planning an exploratory autotomy to conclusive rule out loosening of acetabular and/or metallosis. Additional information received from clinical on (b)(6) 2019: patient had exploratory surgery on (b)(6) 2019 resulting in explant of study devices.
 
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Brand NameCONSERVE® TOTAL A-CLASS® 42MM
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 Key8343754
MDR Text Key136272927
Report Number3010536692-2019-00379
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
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 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AC-4200
Device Catalogue Number38AC-4200
Device Lot Number0411347584
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/16/2019
Event Location No Information
Date Manufacturer Received01/16/2019
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: 02/15/2019 Patient Sequence Number: 1
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