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

Catalog Number 10207101

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

Patient Problem Arthralgia (2355)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that, after a total ankle replacement surgery was performed on (b)(6)2018 the patient experienced severe pain in the ankle joint; no complications on the x-rays.So far, no treatment has been given.However, a surgery procedure has been proposed to the patient; the decision has to be confirmed by the patient.The patient's current health status is ongoing.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: given the nature of the alleged incident, the devices, could not be returned for evaluation.The clinical/medical investigation concluded that, per complaint details, the study patient experienced severe pain in the ankle joint, approximately 3.5 years post right total ankle replacement.Reportedly, no complications on the x-rays and the event is ongoing, the patient was proposed a surgical procedure to treat the pain but has not made the decision known as of the date of this medical investigation.The form documents, the non-serious, anticipated, continuous, severe grade adverse event onset date as 1-jan-2022, and as possibly related to the device but not related to the procedure with no treatment or end date.It is unknown if the patient will proceed with the proposed surgical treatment.It was communicated that the remaining documentation requested was not available.Of note, the adverse event ¿varus positioning of the prosthesis, ankle equinus, ankle ankylosis¿ on 22-sept-2020 onset date was noted in the provided adverse event form; however, based on the limited information provided, the definitive clinical root cause of the reported severe pain, cannot be concluded, and patient impact beyond the reported cannot be determined.No further medical assessment can be rendered at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed similar events for the listed batches, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for cadence total ankle system revealed that pain, discomfort, or abnormal sensations due to the presence of the implant have been identified as possible adverse effects.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Corrected data: g2 (report source updated).

• Brand Name: CADENCE TIBIAL TRAY. SIZE 1. RIGHT
• 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: 17450581
• MDR Text Key: 320305839
• Report Number: 3002788818-2023-00058
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00885556852286
• UDI-Public: 00885556852286
• 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: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• 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 Catalogue Number: 10207101
• Device Lot Number: QJ0704-G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2017
• 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: CADENCE INSERT SZ1 RT 8MM NEUTRAL, LOT#:PN7050-G.; CADENCE TALAR DOME. SIZE 1. RIGHT, LOT#:172702.
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 77 KG