PERSONA PS ARTICULAR SURFACE N/A 42522400712

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-06 for PERSONA PS ARTICULAR SURFACE N/A 42522400712 manufactured by Zimmer Orthopaedic Mfg. Ltd..

MAUDE Entry Details

Report Number3007963827-2019-00256
MDR Report Key8970124
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-09-06
Date of Report2019-09-06
Date of Event2019-07-22
Date Mfgr Received2019-08-13
Device Manufacturer Date2019-01-03
Date Added to Maude2019-09-06
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER ORTHOPAEDIC MFG. LTD.
Manufacturer StreetBUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE
Manufacturer CitySHANNON, COUNTY CLARE
Manufacturer CountryEI
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NamePERSONA PS ARTICULAR SURFACE
Generic NamePROSTHESIS, KNEE
Product CodeOIY
Date Received2019-09-06
Model NumberN/A
Catalog Number42522400712
Lot Number64242659
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER ORTHOPAEDIC MFG. LTD.
Manufacturer AddressBUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE SHANNON, COUNTY CLARE EI


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-09-06

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