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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® BF SHELL 52MM GROUP D HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. DYNASTY® BF SHELL 52MM GROUP D HIP COMPONENT Back to Search Results
Model Number DSBFGD52
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event Description
Allegedly, patient had failed total hip right loose acetabular component patient underwent r hip revision replacement of acetabular shell cup cage, acetabular fracture and loose acetabular component.
 
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Brand NameDYNASTY® BF SHELL 52MM GROUP D
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 Key9182520
MDR Text Key162324433
Report Number3010536692-2019-01087
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
PMA/PMN Number
K082924
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSBFGD52
Device Catalogue NumberDSBFGD52
Device Lot Number1101216630
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/13/2019
Event Location No Information
Date Manufacturer Received09/13/2019
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: 10/11/2019 Patient Sequence Number: 1
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