ARTHROSURFACE TOEMOTION 9P15-PB01-A/ 9P15-S180-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-27 for ARTHROSURFACE TOEMOTION 9P15-PB01-A/ 9P15-S180-A manufactured by Arthrosurface, Inc..

Event Text Entries

[188866559] The patient had provided copies of x-rays on request, which confirmed loosening of the phalangeal component in the bone. The exact cause of reported lucency is unknown. As a part of the investigation, incoming and final inspection records (dhrs) of the lots in question were reviewed and no discrepancies were noted. All parts were built to specification and non-conforming parts were appropriately identified and dispositioned accordingly. The instructions for use (ifu) document states that this type of event can occur, and all risks are addressed in the risk documentation. A valid root cause cannot be established based on available information. 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 patient was advised to get a full work up done by a surgeon which may help in determination of underlying cause(s) of reported loosening. Another mdr was filed for the patient's first toemotion device (mdr #: 3004154314-2019-00011). If additional relevant information is received, it will be reviewed for reportability and submitted via a supplemental mdr. Below is the part and lot information of the patient's second toemotion implant. Pn: 9p15-s180-a, lot # 75ae3004, mfg. Date: 03-2015, exp. Date: 03-2020. Pn: 9p15-pb01-a, lot # 75ae3014, mfg. Date: 02-2015, exp. Date: 02-2020.
Patient Sequence No: 1, Text Type: N, H10


[188866560] Arthrosurface was informed of this event by the patient through a blogpost on the website. The patient received bilateral toemotion implants in 2015 six months apart. At 3 years post-op, the treating surgeon recommended silicone implants and bone grafts to the patient after noticing lucency around the phalangeal implants. Patient also reported that an md recommended considering fusion in a recent visit.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004154314-2019-00012
MDR Report Key9131473
Date Received2019-09-27
Date of Report2019-08-28
Date Mfgr Received2019-08-28
Date Added to Maude2019-09-27
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 Received2019-09-27
Catalog Number9P15-PB01-A/ 9P15-S180-A
Lot Number75AE3014/ 75AE3004
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 2019-09-27

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