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

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.

• Brand Name: CADENCE TIBIAL TRAY, SIZE 2X, RIGHT
• 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: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7753861
• MDR Text Key: 116145558
• Report Number: 1651501-2018-00052
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10207112
• Device Lot Number: QJ0234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2019
• 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: Unknown
• Patient Sequence Number: 1