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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME HIP COMPONENT Back to Search Results
Model Number PHAC1214
Device Problem Corroded (1131)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to corrosion at the neck-stem junction of the device.
 
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Brand NamePROFEMUR NECK A/R VAR/VAL 2 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 Key10401964
MDR Text Key202732282
Report Number3010536692-2020-00571
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 other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPHAC1214
Device Catalogue NumberPHAC1214
Device Lot Number010103980810
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/22/2020
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/13/2020 Patient Sequence Number: 1
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