CS INSRT IMPL SZ 3 LEFT 10MM IMPLANT PARTNERS? EAI3110LWD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-16 for CS INSRT IMPL SZ 3 LEFT 10MM IMPLANT PARTNERS? EAI3110LWD manufactured by Microport Orthopedics Inc..

Event Text Entries

[183882405] This event will be updated once the investigation is complete. Trends will be evaluate.
Patient Sequence No: 1, Text Type: N, H10


[183882406] Allegedly, the patient was implanted with the evolution nitrix (tibial and femoral components) but surgery was completed without a tibia insert because the hospital only had implant partner inserts available which are not indicated for use with the evolution nitrix. The insert was later implanted which would work with the tibial and femoral components. There was a secondary surgery due to a non-compatible insert for the original surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010536692-2020-00239
MDR Report Key9835696
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-16
Date of Report2020-03-16
Date Facility Aware2020-02-27
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street5677 AIRLINE ROAD
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal38002
Manufacturer Phone9018674771
Manufacturer G1MICROPORT ORTHOPEDICS INC.
Manufacturer Street5677 AIRLINE RD.
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal Code38002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCS INSRT IMPL SZ 3 LEFT 10MM IMPLANT PARTNERS?
Generic NameKNEE COMPONENT
Product CodeHRY
Date Received2020-03-16
Model NumberEAI3110LWD
Catalog NumberEAI3110LWD
Lot Number15220061596738.
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMICROPORT ORTHOPEDICS INC.
Manufacturer Address5677 AIRLINE RD. ARLINGTON TN 38002 US 38002


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-16

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