MAUDE Adverse Event Report: ARTHROSURFACE INC. IMPL MTP FIX TOEMOTION DF-P; PROSTHESIS, TOE, HEMI-, PHALANGEAL

Model Number 9P15-S180-W

Patient Problem Insufficient Information (4580)

Event Date 01/30/2024

Event Type  Injury  

Event Description

Total toe implant was opened and implanted into patient.After implantation it was discovered that the plastic cup auto-rotated.As described by reps of the company, this should not have happened.First implant was removed and a second implant was opened and implanted with the same auto-rotation.Reference report #mw5151848.

• Brand Name: IMPL MTP FIX TOEMOTION DF-P
• Type of Device: PROSTHESIS, TOE, HEMI-, PHALANGEAL
• Manufacturer (Section D): ARTHROSURFACE INC.; franklin MA 02038
• MDR Report Key: 18767174
• MDR Text Key: 336286669
• Report Number: MW5151847
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 9P15-S180-W
• Device Catalogue Number: 9P15-S180-W
• Device Lot Number: 75CC8682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White