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 rep who attended the revision case was contacted for further information regarding this incident.Per the rep, the phalangeal component was very well fixated and had to be retrieved using a screw driver for the revision procedure.It was not clear why loosening was indicated on the revision notification form.The complaint could not be confirmed as the device in question or radiographs showing loosening were not provided to arthrosurface for investigation.The device history records (dhrs) of the implant lots in question were reviewed and noted that all parts were built to specification.A valid root cause for the pain or reported loosening cannot be determined based on available information.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.If additional relevant information is received, information will be reviewed for reportability and submitted 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 # 75ch3104, mfg.Date: 04/12/2018, exp.Date: 04/12/2023.Part # 9p15-pa01-w, lot # 75ah2006, mfg.Date: 02/20/2018, exp.Date: 02/20/2025.

Event Description

Arthrosurface received a revision notification on 07/30/2019 regarding a toemotion patient who was revised due to pain.The revision notification form also indicated that the phalangeal fixation component was loose.

• 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: 8945852
• MDR Text Key: 194809460
• Report Number: 3004154314-2019-00009
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• PMA/PMN Number: K132496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/30/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/29/2019
• 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