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

Device Problem Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); Joint Swelling (2356); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

A total toe patient was revised due to pain, swelling and loss of range of motion.

• 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: 7927315
• MDR Text Key: 122374741
• Report Number: 3004154314-2018-00017
• 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: 09/03/2018

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: 09/03/2018
• Initial Date FDA Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other