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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Pain Relief (2388)

Event Type  malfunction  

Manufacturer Narrative

The reason for reported pain could be due to loosened phalangeal component that was noted during the revision surgery.Root cause for loosening was unable to be determined as the device was not returned and necessary information to adequately investigate the reported event was not provided.Since no part and lot information was provided, review of the device history records (dhrs) of devices in question cannot be conducted.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 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 use.If additional relevant information is received, a follow-up report will be submitted.The patient was revised to a fusion and all toemotion components have been explanted.Should arthrosurface receive any further information regarding this event in future, it will be documented and reported accordingly through a supplemental mdr.

Event Description

Toemotion patient revised due to pain.The rep indicated that the phalangeal component was loose and a void was noted surrounding the implant under x-ray.

• 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: 12050320
• MDR Text Key: 257806666
• Report Number: 3004154314-2021-00003
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/27/2021

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
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/23/2021
• 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