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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
Model Number 2600-0025
Device Problems Break (1069); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Allegedly on (b)(6) 2017, the patient was revised due to a fracture at the neck stem-junction. During the revision surgery the neck remnant in the stem was attempted to be removed but after 4 1/2 hours of surgery was determined that the removal of the neck remnant could not be successfully preformed and aborted the procedure. Allegedly on (b)(6) 2017 the patient was revised due to the neck regiment which could not be removed from the stem in the prior surgery on (b)(6) 2017. The surgeon performed a successful extended trochanteric osteotomy to remove the well fixed stem and the neck remnant.
 
Manufacturer Narrative
Updated the incident description to: allegedly the patient was revised due to a broken neck.
 
Event Description
Allegedly the patient was revised due to a broken neck.
 
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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 Key7373407
MDR Text Key103556006
Report Number3010536692-2018-00320
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K004043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number2600-0025
Device Catalogue Number2600-0025
Device Lot Number1505250
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/05/2018
Event Location No Information
Date Manufacturer Received03/05/2018
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: 03/27/2018 Patient Sequence Number: 1
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