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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD MEDIUM NECK 44MM HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD MEDIUM NECK 44MM HIP COMPONENT Back to Search Results
Model Number 38AM4400
Device Problem Malposition of Device (2616)
Patient Problem Unequal Limb Length (4534)
Event Type  Injury  
Event Description
Allegedly, cup was improperly positioned. Leg length difference. Our neck and head came out along w/the shell (w/o cup cutters). Tjo cup, screws (2), liner and head used with our neck. Cultures taken. Bmi 24. 8 right hip. Component not revised: pyrd0004 profemur raz stem lot 067426983.
 
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Brand NameCONSERVE A-CLASS BFH HEAD MEDIUM NECK 44MM
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 Key11116209
MDR Text Key225054140
Report Number3010536692-2021-00002
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AM4400
Device Catalogue Number38AM4400
Device Lot Number077444899
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/22/2020
Event Location No Information
Date Manufacturer Received12/22/2020
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: 01/05/2021 Patient Sequence Number: 1
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