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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 32MM SLT TAPER LONG N; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 32MM SLT TAPER LONG N; HIP COMPONENT Back to Search Results
Model Number 26000023
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to adverse soft tissue reaction to particulate debris revision njr number: (b)(4), side:r, primary asa: p2 - mild disease not incapacitating.
 
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Brand Name
COCR TRANSCEND FEMORAL HEAD 32MM SLT TAPER LONG N
Type of Device
HIP 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 Key12275370
MDR Text Key265123489
Report Number3010536692-2021-00421
Device Sequence Number1
Product Code JDL
UDI-Device IdentifierM684260000231
UDI-PublicM684260000231
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K004043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number26000023
Device Catalogue Number26000023
Device Lot Number87459184
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/14/2021
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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