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

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

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Debris, Bone Shedding (1803); Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

There was no trauma or injury to the patient according to rep who attended the revision case.Arthrosurface obtained feedback from various surgeons regarding post-op images of the implant.The immediate post-op x-ray with a linear opacity around the implant suggests a technical error placing the tap too deep on both sides of the mtp joint which could result in poor fixation immediately and allows debris to get around the implant.Apart from review of the x-rays, device history records (dhrs) of all implant lots in question were reviewed and noted that all parts were manufactured to specification.Additionally, performance history (number of cases recorded) of the implant lots in question was reviewed and noted that no issues or complaints were reported till date.The patient is currently revised to an implant of another manufacturer and all arthrosurface components have been explanted.Arthrosurface will continue to monitor for similar issues.The manufacturing and expiration dates of the phalangeal components in question are: part # 9p15-s180-a, lot # 75ae3004, mfg.Date: 2015-03, exp.Date: 2020-03.Part # 9p15-pb01-a, lot # 75ae3014, mfg.Date: 2015-02, exp.Date: 2020-02.

Event Description

Arthrosurface was notified of a revision case where the patient was revised due to loosening of phalangeal implant and bone loss.

• 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: 7112663
• MDR Text Key: 95596668
• Report Number: 3004154314-2017-00024
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9P15-S180-A & 9P15-PB01-A
• Device Lot Number: 75AE3004 & 75AE3014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2017
• 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