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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 28MM SLT TAPER SHORT HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 28MM SLT TAPER SHORT HIP COMPONENT Back to Search Results
Model Number 26000017
Device Problem Material Disintegration (1177)
Patient Problem Reaction (2414)
Event Date 07/07/2020
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly , the suspicion of adverse reaction to metal debris may be especially between neck and head. Dr. Wants to investigate the existence of adverse reaction to metal debris as following. Used our profemurxm, changeable neck, metal head only and used depuy pina cup and marason liner 28mm diameter flat. A few days ago, the patient complained of abnormal noise from his joint spinning prevention tab of 6 pin cup marathon liner 4 out of 6 damaged. Replace with marathon liner 32mm flat. Our steam is also replaced with a changeable neck ar8 long and a delta head 32 mm long. (b)(6).
 
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Brand NameCOCR TRANSCEND FEMORAL HEAD 28MM SLT TAPER SHORT
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 Key10361494
MDR Text Key201524894
Report Number3010536692-2020-00546
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
PMA/PMN Number
K004043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number26000017
Device Catalogue Number26000017
Device Lot Number1485543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/14/2020
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/04/2020 Patient Sequence Number: 1
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