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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 99-0028/12
Device Problem Degraded (1153)
Patient Problem Failure of Implant (1924)
Event Date 11/20/2014
Event Type  Injury  
Event Description
Star total ankle sliding core mobile bearing was exchanged due to degradation of implant.
 
Manufacturer Narrative
Visual examination confirms that the degradation of the sliding core mobile bearing is consistent with malalignment.The patient's increased weight is contributing factor to the degradation.The dhr for part no.99-0028/12, lot no 1007054 shows no deviations.All released parts were within specification.
 
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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
2153376481
MDR Report Key4316547
MDR Text Key15328547
Report Number3003640913-2014-00091
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 11/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/01/2015
Device Model Number99-0028/12
Device Lot Number1007054
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/25/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/20/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
Patient Weight159
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