HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS PX02-0704-W

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-04 for HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS PX02-0704-W manufactured by Arthrosurface, Inc..

MAUDE Entry Details

Report Number3004154314-2019-00014
MDR Report Key9273766
Date Received2019-11-04
Date of Report2019-10-03
Date Mfgr Received2019-10-03
Device Manufacturer Date2015-02-22
Date Added to Maude2019-11-04
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. PHANI PUPPALA
Manufacturer Street28 FORGE PARKWAY
Manufacturer CityFRANKLIN, MA MA 02038
Manufacturer CountryUS
Manufacturer Postal02038
Manufacturer Phone5085203003
Manufacturer G1PRIMO MEDICAL GROUP
Manufacturer Street75 MILL ST
Manufacturer CitySTOUGHTON, MA 02072
Manufacturer CountryUS
Manufacturer Postal Code02072
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
Generic NameKNEE JOINT PATELLO-FEMORAL RESURFACING PROSTHESIS
Product CodeKRR
Date Received2019-11-04
Catalog NumberPX02-0704-W
Lot Number75BE1711
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARTHROSURFACE, INC.
Manufacturer Address28 FORGE PARKWAY FRANKLIN, MA 02038 US 02038


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.