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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE TIBIAL TRAY, SIZE 2X, RIGHT CADENCE TOTAL ANKLE SYSTEM

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ASCENSION ORTHOPEDICS CADENCE TIBIAL TRAY, SIZE 2X, RIGHT CADENCE TOTAL ANKLE SYSTEM Back to Search Results
Catalog Number 10207112
Device Problems Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)
Patient Problems Bone Fracture(s) (1870); Complaint, Ill-Defined (2331); Injury (2348); No Code Available (3191)
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
Patient indicated she had a cadence implanted on (b)(6) 2016 in her right ankle. Patient had subsequent follow up visits with surgeon and had to have repair surgery. In (b)(6) 2017, she had surgery to repair fracture of bone. At the end of 2017, the patient lost her job and moved to (b)(6) as a result of issues she experienced with cadence. While in colorado, the patient consulted another surgeon, and he advised her that the implant was ¿in varus¿ and recommended being able to do a surgical repair. On (b)(6) 2018, the surgeon removed the implant and replaced the cadence with a competitor implant. No additional information available.
 
Manufacturer Narrative
Dhr - as none of the components in question were returned and lot information was not included with the complaint form, a review of the lot records could not be conducted to discover if there were any indication of problems that could have caused or contributed to the complaint. Failure analysis could not be conducted, and the root cause could not be determined.
 
Manufacturer Narrative
1 of 3 reports - other mfg report numbers: 1651501-2018-00052, 1651501-2019-00002, 1651501-2019-00004. Summary of operative notes: on (b)(6) 1982, patient had a history of ankle repair surgery due to a broken ankle. There were no known complications after the procedure. The patient then underwent second surgery on (b)(6) 2001 to remove the screws and pins (debridement). The patient experienced gradual return of pain and bone spurs after. On (b)(6) the patient underwent right total ankle replacement with cadence total ankle system due to chronic ankle pain. On (b)(6) 2016, patient¿s husband called in and complained that the patient was experiencing sharp burning pain in her big toe and in the space between. The patient was put in cam boot and was on weight bearing as tolerated. The patient was advised to return in four weeks for repeat x-rays and examination with their physician. On (b)(6) 2016 ¿ 7 weeks off from surgery complained of right ankle pain. On x-rays, her tibial component appears to be in varus. Not in previous x-xays. On (b)(6) 2017, patient came in for evaluation after 2 months post-op right total ankle replacement using cadence total ankle system. The patient complained she was having no pain until about 10 days ago, at which point she was having medial malleolus pain. Based from the physical examination performed by the physician, the patient has significant tenderness and some swelling over the medial malleolus. The patient dorsiflexes only to about neutral, so she was a bit stiff. The surgeon suspects she might have an occult periprosthetic fracture of her medial malleolus and ordered a ct scan with metal suppression and advised patient to come back a week after. On (b)(6) 2017, ct scan reveals a periprosthetic medial malleolar fracture that is nondisplaced in nature. With this, the patient agreed to the physician¿s recommendation of undergoing open reduction internal fixation. On (b)(6) 2017, the patient underwent right open reduction internal fixation medial malleolus, strayer. Patient had a stable condition after the operation. Two-week postop evaluation, patient presented with no complications and was put into a short leg cast. However, 3 months after the operation, patient complained of occasional sharp pains under the medial malleolus. Patient also stated that the last three days had some pain in the mid portion of her lateral right leg. Based from the physical examination performed by the physician, the tenderness felt at the musculotendinous junction of the peroneal tendons may be just some peroneal tendonitis. The physician advised her on dietary management, smoking cessation and a rocker bottom soled shoe. Patient was advised to follow up 2 months after.
 
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Brand NameCADENCE TIBIAL TRAY, SIZE 2X, RIGHT
Type of DeviceCADENCE 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
vivian nelson
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key7753861
MDR Text Key116145558
Report Number1651501-2018-00052
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number10207112
Device Lot NumberQJ0234
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2019
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 Unkown

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