ARTHROSURFACE TOEMOTION 9P15-S180/ 9P15-PA01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for ARTHROSURFACE TOEMOTION 9P15-S180/ 9P15-PA01 manufactured by Arthrosurface, Inc.

Event Text Entries

[118558933] The patient received arthrosurface toemotion implants bilaterally on (b)(6) 2016 (left side) and (b)(6) 2016 (right side). According to the surgeon, the right toemotion phalangeal implant loosened over time and led to pain in the patient. However, there are no issues with the left toemotion implant. Copies of operative note and post-op x-ray was provided to arthrosurface. The exact reason for the loosening 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. 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. We will continue to monitor, track and trend. The phalangeal component was removed uneventfully and an interpositional graft was placed while still retaining df implant on the metatarsal side. Following is the information pertaining to explanted devices: part # 9p15-s180; lot: 75af2810; mfg. Date: 05/06/2016; exp. Date: 05/06/2021. Part # 9p15-pa01; lot: 75af0714; mfg. Date: 02/17/2016; exp. Date: 02/17/2023.
Patient Sequence No: 1, Text Type: N, H10


[118558934] Patient underwent revision due to loosening of the toe motion phalangeal component.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004154314-2018-00015
MDR Report Key7819671
Date Received2018-08-27
Date of Report2018-07-27
Date Mfgr Received2018-07-27
Date Added to Maude2018-08-27
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 Received2018-08-27
Catalog Number9P15-S180/ 9P15-PA01
Lot Number75AF2810/ 75AF0714
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARTHROSURFACE, INC
Manufacturer Address28 FORGE PARKWAY FRANKLIN 02038 US 02038


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-27

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