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

Model Number 9P15-S180-W

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

This case is still under investigaton.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.

Event Description

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 08march2024 a medwatch (mw5151847) was received by anika.It was reported that the plastic cup auto rotates.The first implant was removed, and a second implant was used and the same rotation was reported.There was no negative patient impact reported.Additional information was solicited.

Manufacturer Narrative

This case is still under investigaton.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.The reported event is not confirmed.It was reported that the plastic cup auto rotated when the device was first implanted.The same rotation was observed on the second implanted component.There was no delay in the procedure reported and no negative impact to the patient reported.The device was returned to arthrosurface for analysis.The device did not have any issue and the poly rotated as intended with no malfunction.A review of the batch record was performed by the manufacturer.There were no nonconformances in the batch record.The records found are complete and the device was manufactured to specification.The cause was determined to be traced to user training.The reported event will continue to be monitored and trended for future analysis.

Event Description

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 08march2024 a medwatch (mw5151847) was received by anika.It was reported that the plastic cup auto rotates.The first implant was removed, and a second implant was used and the same rotation was reported.There was no negative patient impact reported.Additional information was solicited.

• Brand Name: TOEMOTION TOE ARTHROPLASTY SYSTEM
• Type of Device: PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED
• Manufacturer (Section D): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill street; stoughton MA 02072
• Manufacturer Contact: keith kelly ; 28 forge parkway; franklin, MA 02038
• MDR Report Key: 18981470
• MDR Text Key: 338993108
• Report Number: 3004154314-2024-00003
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9P15-S180-W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1