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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. COCR TRANSCEND® FEMORAL HEAD HIP COMPONENT Back to Search Results
Model Number 2600-0023
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once the investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly the patient had hip replacement surgery on (b)(6) 2014. Revised on (b)(6) 2019 due to pain. Revised femoral head to a different size - mp catalog #26000020. Cup and liner replaced with another manufacturer's implants. Primary surgery was through posterior approach, not superpath. No x-rays or explant photos are available. (b)(6) capa# (b)(4).
 
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Brand NameCOCR TRANSCEND® FEMORAL HEAD
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 Key8408315
MDR Text Key138396024
Report Number3010536692-2019-00521
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K004043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number2600-0023
Device Catalogue Number2600-0023
Device Lot Number1101241565
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/27/2019
Event Location No Information
Date Manufacturer Received02/27/2019
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: 03/11/2019 Patient Sequence Number: 1
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