ARTHROSURFACE TOEMOTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-12 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..

Event Text Entries

[114154385] The patient received two arthrosurface toemotion implants bilaterally and implanted one year apart. However, the exact dates are unknown. This report is for the second arthrosurafce toemotion device. The report for the first device is filed under mdr# "3004154314-2018-0013. " the reason for reported loosening is unknown. Root cause was unable to be determined as the device was not returned and necessary information to adequately investigate the reported event was not provided. Since no part and lot information was provided, review of the device history records (dhrs) of devices in question cannot be conducted. The instructions for use (ifu) document states that this type of event can occur and all risks are addressed in the risk documentation. The rep who attended the revision case stated that the patient's bone quality could have been a factor. Several factors such as stress/ physical loads on the implants, vascularity of the implantation site, surgical techniques employed during implantation, patient factors (such as age, current state of the immune system, bone quality, and sensitivity to device materials), and patient post-op compliance to rehabilitation procedures etc. , can have impact on the functional effectiveness of the implanted devices. The implant materials and combinations have decades of history for use in joint replacement applications. Also, the implant materials have been evaluated for biocompatibility to demonstrate safety for intended purposes. If additional relevant information is received, a follow-up report will be submitted. The patient was revised to a new set of toemotion components and the surgeon was satisfied with the outcome. Should arthrosurface receive any further information regarding this event in future, it will be documented and reported accordingly through a supplemental mdr.
Patient Sequence No: 1, Text Type: N, H10


[114154386] Arthrosurface was notified of a revision case where the patient had bilateral toemotion implants loosened.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004154314-2018-00014
MDR Report Key7683335
Date Received2018-07-12
Date of Report2018-06-13
Date Mfgr Received2018-06-13
Date Added to Maude2018-07-12
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 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 NameARTHROSURFACE TOEMOTION
Generic NameARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT
Product CodeLZJ
Date Received2018-07-12
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 2018-07-12

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