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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 Insufficient Information (3190)
Patient Problems Pain (1994); Unequal Limb Length (4534)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to pain and limb length discrepancy in her right hip. All products were replaced.
 
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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 Key10750869
MDR Text Key213635713
Report Number3010536692-2020-00668
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082924
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSBFGD52
Device Catalogue NumberDSBFGD52
Device Lot Number1426843
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/07/2020
Event Location No Information
Date Manufacturer Received10/07/2020
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: 10/28/2020 Patient Sequence Number: 1
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