MAUDE Adverse Event Report: ARTHROSURFACE, INC. ARTHROSURFACE TOEMOTION; ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT

Catalog Number 9P15-PB01-A/ 9P15-S180-A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.A second mdr was filed for the patient's other toemotion device (mdr #: 3004154314-2019-00012).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 first toemotion implant.Pn: 9p15-s180-a, lot # 75id0219, mfg.Date: 09-2014, exp.Date: 09-2019.Pn: 9p15-pb01-a, lot # 75id0208, mfg.Date: 11-2014, exp.Date: 11-2019.

Event Description

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.

• Brand Name: ARTHROSURFACE TOEMOTION
• Type of Device: ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin, ma 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill st; stoughton, ma 02072
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, ma 02038 ; 5085203003
• MDR Report Key: 9131457
• MDR Text Key: 188866789
• Report Number: 3004154314-2019-00011
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9P15-PB01-A/ 9P15-S180-A
• Device Lot Number: 75ID0208/ 75ID0219
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other