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

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

From the radiographs provided by the patient, lucency was noted around the phalangeal implant indicating loosening.The cause for reported issue is unknown.The device is unable to be returned for investigation as it remains implanted in the patient.The device history records of the implant lots in question were reviewed and noted that each lot was built to established specifications.The non-conforming parts were appropriately identified and segregated accordingly.The instructions for use (ifu) document states that this type of event can occur and all risks are addressed in the risk documentation.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.Per initial information, the patient is currently planning on a revision to a fusion.The patient has since not responded to follow-up attempts.Should arthrosurface receive any further information regarding this event in future, it will be documented and reported accordingly through a supplemental mdr.Below is the information related to the implanted device.Part # 9p15-pb01-w , lot # 75gf0711, mfg.Date: 08/10/2016, exp.Date: 08/10/2023; part # 9p15-s180-w , lot # 75hf0209, mfg.Date: 08/08/2016 , exp.Date: 08/08/2021.

Event Description

An arthrosurface regional manager was contacted by a toemotion patient who is seeking referral surgeon information.It was learned that the patient has lucency around the implant.

• Brand Name: ARTHROSURFACE TOEMOTION
• Type of Device: ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill st; stoughton MA 02072
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin 02038 ; 5085203003
• MDR Report Key: 7911839
• MDR Text Key: 122036089
• Report Number: 3004154314-2018-00016
• 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: 08/26/2018

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: 08/26/2018
• Initial Date FDA Received: 09/26/2018
• 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