MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. CADENCE TIBIAL TRAY. SIZE 1X. LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 10207211

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Rupture (2208)

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a total ankle replacement surgery was performed on (b)(6) 2018 with a cadence total ankle system, the patient presented anterior impingement, tibialis posterior adherences to the malleolus and too much pressure (m5).This adverse event was treated with physical therapy, a percutaneous osteotomy of m5, release of the tibialis posterior tendinopathy and an anterior ankle arthroscopy.This adverse event is ongoing.

Manufacturer Narrative

Results of investigation: the product has not been received at the aus site for evaluation and photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified similar reported events for this device.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Clinical/medical evaluation: per the provided crfs, no intraoperative complications occurred.Further, the cfrs noted the event was not related to the study device.Per case details, physical therapy and an anterior ankle arthroscopy with a percutaneous osteotomy m5, tibialis posterior tendon release was performed to treat the patient.A review of the crf did not provide further insight into the reported issue of ¿anterior impingement, tibialis posterior adherences to the malleolus and too much pressure m5.¿ therefore, no conclusions could be rendered.The complaint alleges that revision surgery was required.As the product has not been received for evaluation, it could not be determined whether the device contributed to the reported event.As the product has not been received for evaluation, a definitive root cause for the reported event could not be determined.The tibial tray is one of three sterile, implantable components comprising the cadence total ankle system.The complaint alleges that the patient experienced impingement and pain several years after the implantation of the cadence total ankle system and was successfully treated with revision surgery.According to risk documentation for the cadence system, potential causes for the reported event include incorrect surgical technique and incorrect patient selection.Based on this investigation, the need for corrective action is not indicated as no non-conformances or manufacturing deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.

• Brand Name: CADENCE TIBIAL TRAY. SIZE 1X. LEFT
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17099817
• MDR Text Key: 316896056
• Report Number: 3002788818-2023-00043
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00885556852422
• UDI-Public: 00885556852422
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K151459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: 10207211
• Device Catalogue Number: 10207211
• Device Lot Number: QJ0703-G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 10208201/QJ0702-1-G/CADENCE TALAR DOME. SIZE 1. LE; 10209118/PN6897-G/CADENCE INSERT SZ1 LT 8MM NEUTRA
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 110 KG