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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 Loose or Intermittent Connection (1371)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event Description
Allegedly, patient presented with pain. Removal of dynasty cup for loosening. No acute injury of patient. Mpo implants were removed and replaced with another suppliers implants.
 
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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 Key9083720
MDR Text Key159054884
Report Number3010536692-2019-01039
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K082924
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberDSBFGD52
Device Catalogue NumberDSBFGD52
Device Lot Number1726439
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/21/2019
Event Location No Information
Date Manufacturer Received08/21/2019
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: 09/18/2019 Patient Sequence Number: 1
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