RESTORATION ADM X3 INS 28/48 1236-2-848

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-03 for RESTORATION ADM X3 INS 28/48 1236-2-848 manufactured by Stryker Orthopaedics-mahwah.

MAUDE Entry Details

Report Number0002249697-2020-00015
MDR Report Key9546258
Report SourceCONSUMER
Date Received2020-01-03
Date of Report2020-03-18
Date of Event2018-03-23
Date Mfgr Received2020-02-18
Device Manufacturer Date2017-05-13
Date Added to Maude2020-01-03
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. COLLIN NEITZEL
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER ORTHOPAEDICS-CORK
Manufacturer StreetIDA INDUSTRIAL ESTATE
Manufacturer CityCARRIGTWOHILL NJ NA
Manufacturer CountryIE
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRESTORATION ADM X3 INS 28/48
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Product CodeMEH
Date Received2020-01-03
Catalog Number1236-2-848
Lot Number59797801
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ORTHOPAEDICS-MAHWAH
Manufacturer Address325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-03

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