MAUDE Adverse Event Report: ARTHROSURFACE, INC. HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT; TOE JOINT PHALANGEAL (HEMI-TOE) POLYMER PROSTHESIS

Catalog Number 9M52-1535-W, 9095-0018-W

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/19/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Patient is experiencing pain on plantar flexion and complained of the same, during the two post-op follow up sessions with implanting surgeon.On visiting a second treating surgeon, patient recently learned that the implant is moving and is loosened.Efforts are being made by arthrosurface to understand the issues underlying the complaint.Discussions with another physician for second opinion are in progress.A supplemental report will be filed as required.Following are the details of the components that were implanted in patient.Part # 9m52-1535-w, lot # 75fc1006, mfg dt: 06/2013, exp dt: 06/2020.Part # 9095-0018-w, lot # 75jc1716, mfg dt: 10/2013, exp dt: 10/2018.

Event Description

Patient contacted arthrosurface via website to report the pain being caused by hemicap that was implanted in the great toe since (b)(6) 2014.Patient questioned if implant could be loose.

• Brand Name: HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
• Type of Device: TOE JOINT PHALANGEAL (HEMI-TOE) POLYMER PROSTHESIS
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): ARTHROSURFACE, INC.; 28 forge parkway; franklin MA 02038
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 5238840
• MDR Text Key: 31702045
• Report Number: 3004154314-2015-00005
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• PMA/PMN Number: K131377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 9M52-1535-W, 9095-0018-W
• Device Lot Number: 75FC1006, 75JC1716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2015
• 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
• Patient Age: 56 YR