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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMALL BONE INNOVATIONS, INC. STAR TOTAL ANKLE REPLACEMENT; SLIDING CORE MOBILE BEARING
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SMALL BONE INNOVATIONS, INC. STAR TOTAL ANKLE REPLACEMENT; SLIDING CORE MOBILE BEARING Back to Search Results
Model Number 400-142
Device Problem Degraded (1153)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 01/21/2015
Event Type  Injury  
Event Description
Star total ankle replacement sliding core mobile bearing was exchanged due to pain associated with implant wear.
 
Manufacturer Narrative
There was no deviations reported in the dhr for part no.400-142, lot 0920104.All released parts were within spec.The company's surgery report form indicates there was wear on the sliding core mobile bearing.
 
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Brand Name
STAR TOTAL ANKLE REPLACEMENT
Type of Device
SLIDING CORE MOBILE BEARING
Manufacturer (Section D)
SMALL BONE INNOVATIONS, INC.
morrisville PA
Manufacturer Contact
steve ward
1380 s. pennsylvania ave.
morrisville, PA 19067
2153376436
MDR Report Key4538964
MDR Text Key5514250
Report Number3003640913-2015-00004
Device Sequence Number1
Product Code NTG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 01/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/01/2014
Device Model Number400-142
Device Lot Number0920104
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/17/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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