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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 36MM SLT TAPER MEDIUM HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 36MM SLT TAPER MEDIUM HIP COMPONENT Back to Search Results
Model Number 26000026
Device Problem Insufficient Information (3190)
Patient Problem Reaction (2414)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to adverse soft tissue reaction to particle debris. Revision njr number: (b)(4). Side:r. Primary asa: p3 - incapacitating systemic disease. Components not revised: procotyl l beaded and ha coated cup size 54mm, product id pha06264, lot id 38536091. Profemur® l hip stem size 3 ha coated, product id pha05506, lot id 38563974. Profemur® neck neutral short, product id pha01202, lot id 108693562.
 
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Brand NameCOCR TRANSCEND FEMORAL HEAD 36MM SLT TAPER MEDIUM
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 Key10337678
MDR Text Key206558413
Report Number3010536692-2020-00507
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K004043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number26000026
Device Catalogue Number26000026
Device Lot Number38564680
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/15/2020
Event Location No Information
Date Manufacturer Received07/15/2020
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: 07/29/2020 Patient Sequence Number: 1
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