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U.S. Department of Health and Human Services

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

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ARTHROSURFACE INC. IMPL MTP FIX TOEMOTION DF-P; PROSTHESIS, TOE, HEMI-, PHALANGEAL Back to Search Results
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.
 
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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 Key18767174
MDR Text Key336286669
Report NumberMW5151847
Device Sequence Number1
Product Code KWD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model Number9P15-S180-W
Device Catalogue Number9P15-S180-W
Device Lot Number75CC8682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/22/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age51 YR
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite
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