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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CERAMIC FEMORAL HEAD; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CERAMIC FEMORAL HEAD; HIP COMPONENT Back to Search Results
Model Number 26000011
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, patient suffered subluxating and pain." patient needs more offset".Head and liner were pulled and our 15 degrees liner was used along with a tjo 36mm ceramic +7mm head.
 
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Brand Name
CERAMIC FEMORAL HEAD
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9601332
Report Number3010536692-2020-00056
Device Sequence Number503600
Product Code MRA
UDI-Device IdentifierM684260000111
UDI-PublicM684260000111
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
P030027
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/03/2020
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
Operator of Device Other
Device Model Number26000011
Device Catalogue Number26000011
Device Lot Number1548178
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/20/2019
Initial Date Received by Manufacturer 12/20/2019
Supplement Date Received by Manufacturer12/20/2019
Initial Report FDA Received Date01/17/2020
Supplement Report FDA Received Date09/03/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age71 YR
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