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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® HEAD HIP COMPONENT Back to Search Results
Model Number 38AM-4800
Device Problems Material Disintegration (1177); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Reaction (2414)
Event Type  Injury  
Event Description
Allegedly the patient was revised due to mom complications:detached; disconnect; created metallic debris; and/or loosened from acetabulum; debilitating pain; decreased mobility and emotional distress. (right).
 
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Brand NameCONSERVE® 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 Key7861754
MDR Text Key119734515
Report Number3010536692-2018-01172
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AM-4800
Device Catalogue Number38AM-4800
Device Lot Number046337961
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/07/2018
Event Location No Information
Date Manufacturer Received09/07/2018
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: 09/10/2018 Patient Sequence Number: 1
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