MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CADENCE IMPLANT-UNSPECIFIED; CADENCE TOTAL ANKLE SYSTEM|

Catalog Number XXX-CADENCE IMPLANT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Tissue Damage (2104)

Event Type  Injury  

Event Description

It was reported the surgeon appreciated a fracture of the posterior malleolus during a 6 week (postoperative) follow up visit.The fractured was identified via lateral x-ray.It was reported that patient injury was unknown.Additional information was received.The patient underwent a total ankle arthroplasty using the cadence taa approximately 6 weeks prior ((b)(6) 2016).X-ray confirmed a fracture of the posterior malleolus.The surgeon reports he does not feel the fracture is a result of a failure of the device.He reports he does not anticipate any functional problem for the patient due to the incident.The patient followed postoperative instructions.Revision surgery is not planned.The device appears to be functioning well.The patient is feeling well.The patient¿s current condition is ¿normal post operative course.¿.

Manufacturer Narrative

Integra completed its internal investigation 13dec2016.The investigation included: method: - review of device history records.- review of complaint management database for similar complaints.Results: the complaint report does not include the device lot number; therefore, a dhr review could not be conducted.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 three complaints of fractured tibial trays have been received during the lifetime of the product.The complaint rate was calculated based on the number of devices affected by the hazardous situation or failure mode, over the number of surgeries or units sold during the period of the review.Complaint rate: (b)(4).Conclusion: the device was not returned to integra for evaluation.The most probable root cause for the presence of a tibial posterior fracture is when the implant is inserted and impacted at an angle resulting in the fins fracturing the bone.

• Brand Name: CADENCE IMPLANT-UNSPECIFIED
• Type of Device: CADENCE TOTAL ANKLE SYSTEM|
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6143020
• MDR Text Key: 61401313
• Report Number: 1651501-2016-00046
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K151459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CADENCE IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2017
• 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 Number: 1
• Patient Outcome(s): Other