STEM: AMISTEM H HA COATED STD STEM SIZE 3 01.18.133

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 2020-03-24 for STEM: AMISTEM H HA COATED STD STEM SIZE 3 01.18.133 manufactured by Medacta International Sa.

MAUDE Entry Details

Report Number3005180920-2020-00188
MDR Report Key9872424
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-02-25
Date Mfgr Received2020-02-26
Device Manufacturer Date2014-03-07
Date Added to Maude2020-03-24
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 ContactMR. STEFANO BAJ
Manufacturer StreetSTRADA REGINA
Manufacturer CityCASTEL SAN PIETRO, SWITZERLAND 6874CHE
Manufacturer CountrySZ
Manufacturer Postal6874 CHE
Manufacturer G1MEDACTA INTERNATIONAL SA
Manufacturer StreetSTRADA REGINA CASTEL SAN PIETRO 6874, SZ
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTEM: AMISTEM H HA COATED STD STEM SIZE 3
Generic NameHIP CEMENTLESS STEM
Product CodeLZO
Date Received2020-03-24
Model Number01.18.133
Catalog Number01.18.133
Lot Number136187
Device Expiration Date2019-01-31
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDACTA INTERNATIONAL SA
Manufacturer AddressSTRADA REGINA CASTEL SAN PIETRO, 6874,CHE SZ 6874, CHE


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-24

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