MAUDE Adverse Event Report: ARTHROSURFACE, INC. TOEMOTION; PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED

Catalog Number 9M52-2545-W, 9P15-S180-A

Device Problem Insufficient Information (3190)

Patient Problems Joint Swelling (2356); Inadequate Pain Relief (2388)

Event Date 10/21/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Patient has ongoing anatomical issues since childhood.She believes that she developed arthritis from injury long ago.Efforts are being made by arthrosurface to understand the issues relative to the implant and the patient.Following up with the patient.A supplemental report will be filed to address all the concerns.Following is the manufacturing information of the patient's components: part # 9m52-2545-w, lot # 75be0409, mfg dt: 02-2015, exp dt: 02-2022.Part # 9p15-s180-a , lot # 75id0436, mfg dt: 09-2014, exp dt: 09-2019.Part # 9095-0018-w, lot # 75jd2821, mfg dt: 11-2014, exp dt: 11-2019.Part # 9p15-pb01-a, lot # 7dd0709 , mfg dt: 04-2014, exp dt: 04-2019.

Event Description

Patient had a hemicap mtp implant surgery on (b)(6) 2015 which was revised to a total toe on (b)(6) 2015 due to the excessive pain following surgery.Patient is unsatisfied with current pain level and range of motion.

Manufacturer Narrative

Arthrosurface regularly followed-up with the patient to assist with her questions and concerns since the initial complaint.Patient records were obtained and comments from an independent opinion have been forwarded to the patient as her treating physician was on out on medical leave.Patient met and started treatment with a referral physician in her area.The referral physician expressed/ believes that either a scar tissue crowding or a damaged nerve could be causing pain and sensitivity.The patient did get some relief with the initial treatment and will continue treatment with the new physician.The complaint is considered closed at this time.Any additional issues shall be reported as required.

• Brand Name: TOEMOTION
• Type of Device: PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED
• 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: 5237389
• MDR Text Key: 31649684
• Report Number: 3004154314-2015-00006
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

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: Physician
• Device Catalogue Number: 9M52-2545-W, 9P15-S180-A
• Device Lot Number: 75BE0409, 75ID0436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• 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: 43 YR