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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD HIP COMPONENT Back to Search Results
Catalog Number 2600-0023
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 08/07/2017
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly the original surgery was preformed on (b)(6) 2013. The surgeon found a protrusion acetabula about 4 years after. So the surgeon performed tha. The surgeon suspects armd about this incident.
 
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Brand NameLINEAGE(R) TRANSCEND(R) SUPERFINISHED 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 Key6839170
MDR Text Key84418315
Report Number3010536692-2017-01162
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number2600-0023
Device Lot Number1489820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date08/23/2017
Event Location No Information
Date Manufacturer Received08/23/2017
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: 09/01/2017 Patient Sequence Number: 1
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