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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Further to her initial email, the patient added that her toe has currently a bunion like appearance and that she is experiencing discomfort in regular footwear which has never been a concern even with the bone spurs/ protrusions on the first toe due to a childhood injury.As a part of complaint investigation, a review of the dhrs of the patient's implant was conducted and verified that all devices were built to specification.Patient provided x-ray copies of pre-op, post-op at 4 weeks and 8 weeks to arthrosurface showing a slight gap between the first and second metatarsals.X-rays showed no signs of loosening or malorientation of the implant.The exact reason for shifting of the patient's toe is unknown and cannot be concluded with the limited information available for investigation.An orthopedic physician consulted by arthrosurface expressed that there is no issue with the implant and patient needs her tmt joint to be evaluated and may require a lapidus procedure.This information was relayed to the patient.Any further information received from the patient will be reviewed for reportability and submitted accordingly.Below are the device components implanted in the patient.Part # 9m52-2545-w, lot #75ei0237, mfg.Date: 05/23/2019, exp.Date: 05/23/2026.Part # 9095-0018-w, lot #75gi3154, mfg.Date: 08/14/2019, exp.Date: 08/14/2024.Part # 9p15-pb01-w, lot #75ei0210, mfg.Date: 05/06/2019, exp.Date: 05/06/2026.Part # 9p15-s180-w, lot #75gi0155, mfg.Date: 07/08/2019, exp.Date:07/08/2024.

Event Description

The patient received arthrosurface toemotion implant in (b)(6) 2019.According to the email, her great toe started to bend towards the neighboring toe in less than a month following the surgery and currently concerned if the implant is resulting in the shifting.

• 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 MA 02072
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, ma 02038 ; 5085203003
• MDR Report Key: 9678288
• MDR Text Key: 190134201
• Report Number: 3004154314-2020-00001
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 02/06/2020
• 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