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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 32MM SLT TAPER MEDIUM; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 32MM SLT TAPER MEDIUM; HIP COMPONENT Back to Search Results
Model Number 26000022
Health Effect - Clinical Code Metal Related Pathology (4530)
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 revised due to evidence of pseudotumor and corrosion.Changes on the female side of the taper and on the male side to a lesser degree (right hip).
 
Additional Manufacturer Narrative
Corrected data section h.6.Adverse event problem: codes updated.
 
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Brand Name
COCR TRANSCEND FEMORAL HEAD 32MM SLT TAPER MEDIUM
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key12178721
Report Number3010536692-2021-00401
Device Sequence Number20011868
Product Code JDL
UDI-Device IdentifierM684260000221
UDI-PublicM684260000221
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
K004043
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 09/25/2021
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 Number26000022
Device Catalogue Number26000022
Device Lot Number1414825
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/21/2021
Initial Date Received by Manufacturer 06/21/2021
Supplement Date Received by Manufacturer06/21/2021
06/21/2021
Initial Report FDA Received Date07/15/2021
Supplement Report FDA Received Date09/14/2021
09/25/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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