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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE TIBIAL TRAY, SIZE 4X, LEFT; CADENCE TOTAL ANKLE SYSTEM

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ASCENSION ORTHOPEDICS CADENCE TIBIAL TRAY, SIZE 4X, LEFT; CADENCE TOTAL ANKLE SYSTEM Back to Search Results
Catalog Number 10207214
Device Problems Fracture (1260); Device Operates Differently Than Expected (2913)
Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2016
Event Type  Injury  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.
 
Event Description
It was reported that upon impaction of tibial tray, the posterior fragment of the patient's tibia fractured at location of posterior fin on tibial implant.Additional information was requested and the following was received on september 29, 2016: surgeon was not concerned with injury because this fracture will heal on its own.Device remains implanted.Revision surgery will be needed in the future only if the tibial tray does not seat properly.
 
Manufacturer Narrative
Integra has completed their internal investigation on november 10, 2016.The investigation included: methods: review of device history records, review of complaints history.Results: dhr review; no lot number was provided therefore the manufacturing record could not be determined.Complaints history; a review of the complaint records for the same product (or similar products within the product family) for the alleged hazardous situation/failure mode received, determined 3 complaints of fractured tibial trays have been received during the lifetime of the product as specified in the risk management plan (rmp), typically 5 years or within the stated timeframe.Conclusion: a root cause could not be determined due to the absence of the devices to evaluate.Based on the description provided, potential causes for the breakage could be factors such as stress placed upon the medial side of the ankle from the syndesmosis (connective tissues) and performing procedures with hard bone.In addition, if the tibial trays seating is misaligned, the engagement of the posterior fin could potentially fracture the posterior aspect of the tibia during impacting.In this particular case, the surgeon was not concerned and believes that it will heal and that the anterior cortex is covered and well affixed in the hard bone.
 
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Brand Name
CADENCE TIBIAL TRAY, SIZE 4X, LEFT
Type of Device
CADENCE TOTAL ANKLE SYSTEM
Manufacturer (Section D)
ASCENSION ORTHOPEDICS
8700 cameron road #100
8700 cameron road #100
austin TX 78754
Manufacturer (Section G)
ASCENSION ORTHOPEDICS
8700 cameron road #100
austin TX 78754
Manufacturer Contact
sonia irizarry
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key5998146
MDR Text Key56444094
Report Number1651501-2016-00037
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
PMA/PMN Number
K151459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/12/2016
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 Operator Health Professional
Device Catalogue Number10207214
Device Lot NumberQJ0247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/12/2016
Initial Date FDA Received10/04/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age61 YR
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