CAP - GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-08-22 for CAP - GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT manufactured by Arthrosurface, Inc..

Event Text Entries

[83249537] Arthrosurface has limited information regarding this case from the source document received. The device was not returned for investigation. As no part number and lot number were provided, the manufacturing history of implant device(s) installed in the patient could not be reviewed. A cause for this specific event cannot be ascertained from the information provided. If additional information becomes available, a supplemental mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[83249538] Arthrosurface was notified of the information that a patient implanted with toe hemicap underwent revision surgery on (b)(6) 2017 due to chronic pain in his toe.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004154314-2017-00011
MDR Report Key6810712
Report SourceDISTRIBUTOR,FOREIGN
Date Received2017-08-22
Date of Report2017-07-26
Date of Event2017-04-10
Date Mfgr Received2017-07-26
Date Added to Maude2017-08-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR PHANI PUPPALA
Manufacturer Street28 FORGE PARKWAY
Manufacturer CityFRANKLIN 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 Report3

Device Details

Brand NameCAP - GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
Generic NameTOE JOINT, PHALANGEAL (HEMI-TOE) PROSTHESIS
Product CodeKWD
Date Received2017-08-22
OperatorPHYSICIAN
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 2017-08-22

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