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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK NEUTRAL SHORT COBALT CHROME HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PROFEMUR NECK NEUTRAL SHORT COBALT CHROME HIP COMPONENT Back to Search Results
Model Number PHAC1202
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly, infected all implants will be pulled.
 
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Brand NamePROFEMUR NECK NEUTRAL SHORT COBALT CHROME
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 Key9491195
MDR Text Key173739584
Report Number3010536692-2019-01199
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPHAC1202
Device Catalogue NumberPHAC1202
Device Lot Number0801192249
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/22/2019
Event Location No Information
Date Manufacturer Received11/22/2019
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 Initial

Patient Treatment Data
Date Received: 12/18/2019 Patient Sequence Number: 1
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