ARTHROSURFACE TOEMOTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-02 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..

Event Text Entries

[122374741] The patient received toe-motion implant in (b)(6) 2017. Per the rep who attended the revision case, the reported pain, swelling and loss of range of motion were attributed to the loosening of phalangeal component. Root cause was unable to be determined as the device was not returned. The device history records (dhrs) of the implant lots in questions were reviewed and noted that all parts were built to specification. Non-conforming parts have been properly identified and segregated during the inspection process. The instructions for use (ifu) document states that reported events can occur, and all risks are addressed in the risk documentation as a apart of the design control. 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, information will be reviewed and complaint file will be amended accordingly. The patient was revised to a fusion and all arthrosurface devices have been explanted. Following is the information of implants in question. Part # 9p15-s180-w, lot # 75af2810, mfg. Date: 05/06/2016, exp. Date: 05/06/2021. Part # 9p15-pb01-w, lot # 75cf3110, mfg. Date: 05/11/2016, exp. Date: 05/06/2023.
Patient Sequence No: 1, Text Type: N, H10


[122374742] A total toe patient was revised due to pain, swelling and loss of range of motion.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004154314-2018-00017
MDR Report Key7927315
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-10-02
Date of Report2018-09-03
Date Mfgr Received2018-09-03
Date Added to Maude2018-10-02
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 Report3

Device Details

Brand NameARTHROSURFACE TOEMOTION
Generic NameARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT
Product CodeLZJ
Date Received2018-10-02
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 2018-10-02

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