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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE HM FEMORAL COMPONENT CEMENTED 52MM; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE HM FEMORAL COMPONENT CEMENTED 52MM; HIP COMPONENT Back to Search Results
Model Number 38HM1052
Device Problem Material Disintegration (1177)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
Allegedly, patient has been experiencing pain in his left hip and high levels of chromium and cobalt were confirmed by a blood test.Additional information received on 07/30/2020: adding scheduled revision surgery date and patient name.
 
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Brand Name
CONSERVE HM FEMORAL COMPONENT CEMENTED 52MM
Type of Device
HIP 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 Key10428832
MDR Text Key203636434
Report Number3010536692-2020-00584
Device Sequence Number1
Product Code LZO
UDI-Device IdentifierM68438HM10521
UDI-PublicM68438HM10521
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062960
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number38HM1052
Device Catalogue Number38HM1052
Device Lot Number11638949010
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/30/2020
Initial Date Manufacturer Received 07/30/2020
Initial Date FDA Received08/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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