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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 2600-0026
Device Problems Loose or Intermittent Connection (1371); Unstable (1667)
Patient Problem Pain (1994)
Event Date 05/15/2018
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly the patient was revised due to implant loosening causing pain and instability.
 
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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 Key7533005
MDR Text Key108871461
Report Number3010536692-2018-00670
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
Type of Report Initial,Followup
Report Date 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number2600-0026
Device Catalogue Number2600-0026
Device Lot Number048575586
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/16/2018
Event Location No Information
Date Manufacturer Received05/16/2018
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: 05/22/2018 Patient Sequence Number: 1
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