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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R 8DG LONG COBALT CHROME HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R 8DG LONG COBALT CHROME HIP COMPONENT Back to Search Results
Model Number PHAC1234
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 07/08/2020
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly, the patient was revised due to femoral neck failed breaking in two pieces at the neck-stem junction.
 
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Brand NamePROFEMUR NECK A/R 8DG LONG 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 Key11773358
MDR Text Key248982466
Report Number3010536692-2021-00274
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPHAC1234
Device Catalogue NumberPHAC1234
Device Lot Number1400336
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/16/2021
Event Location No Information
Date Manufacturer Received04/16/2021
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: 05/04/2021 Patient Sequence Number: 1
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