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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND® FEMORAL HEAD 32MM HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. COCR TRANSCEND® FEMORAL HEAD 32MM HIP COMPONENT Back to Search Results
Model Number 2600002X
Device Problem Material Disintegration (1177)
Patient Problem Reaction (2414)
Event Type  Injury  
Event Description
Allegedly, the hip was revised due to metallosis behind cup. The patient was revised to stryker shell with change of femoral head. Products not revised: perfecta® rs ii standard flare collarless size 14. 2 39021420.
 
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Brand NameCOCR TRANSCEND® FEMORAL HEAD 32MM
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 Key9440145
MDR Text Key169920334
Report Number3010536692-2019-01170
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number2600002X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/14/2019
Event Location No Information
Date Manufacturer Received11/14/2019
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: 12/09/2019 Patient Sequence Number: 1
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