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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 2600-0026
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly, patient was revised due to implant fracture head. Revision njr number: (b)(6). Primary asa: p1 -fit and healthy.
 
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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 Key6538960
MDR Text Key74236920
Report Number3010536692-2017-00621
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUK
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 04/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number2600-0026
Device Lot Number77455258
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/11/2017
Event Location No Information
Date Manufacturer Received04/11/2017
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: 05/02/2017 Patient Sequence Number: 1
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