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

Catalog Number 9M52-2535-W/ 9P15-PB01-A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/29/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Patient is currently not happy with the amount of pain relief she is able to get after the surgery.But, satisfied with the range of motion.The treating surgeon scheduled patient for re-cementing the components.Arthrosurface is following up with the patient and monitoring the progress.A supplemental report will be filed as required to provide updates on patient's condition.Following are the details of components implanted in the patient: part # 9m52-2535-w lot # 75jd2904 mfg dt: 12-2014 exp dt: 12-2021.Part # 9095-0018-w lot # 75be2522 mfg dt: 03-2015 exp dt: 03-2020.Part # 9p15-s180-a lot # 75id0436 mfg dt: 09-2014 exp dt: 09-2019.Part # 9p15-pb01-a lot # 75id0208 mfg dt: 10-2014 exp dt: 10-2019.

Event Description

Patient contacted arthrosurface to report pain and other on-going issues associated with the right toe after having implanted with toe motion components.Patient wants to be healthy, not be in constant pain and is looking for any advice that arthrosurface could provide with regard to those issues.

Manufacturer Narrative

The patient was revised to a non-arthrosurface toe implant on (b)(6) 2015.The arthrosurface components were removed from the patient and the revision was completed without any issue.It is not known how the implant loosened.Patient has had multiple surgeries before and after several discussions, we learned that patient has a device loosening history.Given patient's device loosening history and early weight bearing, it is possible that implant might have loosened.The complaint is considered closed at this time.

Manufacturer Narrative

This supplemental report is being filed as per patient's recent ((b)(6) 2015) email regarding the date of revision surgery.The revision date was corrected to (b)(6) 2015.Work-up for ruling out any infections and metal allergy had been done prior to the revision date.On (b)(6) 2015, patient met surgeon for anesthesia and pre-op check up.No other reportable information.

• 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: 5250336
• MDR Text Key: 32142058
• Report Number: 3004154314-2015-00007
• 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,Followup
• Report Date: 11/23/2015

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: 9M52-2535-W/ 9P15-PB01-A
• Device Lot Number: 75JD2904/ 75ID0208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/10/2015; 12/28/2015
• 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: 35 YR