MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. UNKN CADENCE IMPL; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKN2400104

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problems Deformity/ Disfigurement (2360); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that, after total ankle replacement surgery had been performed on an unknown date, the unspecified cadence ankle implant still encroaching on the medial malleolus and there is a concern for malrotation, also the patient walked with the leg externally rotated.This adverse event is planned to be solved by revision surgery which has not been scheduled yet.By the moment that surgeon was hoping for the jigs/report could address this problem.Current health status of patient is unknown.No further information is available at the moment.

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, two undated, unlabeled images were provided that confirm the implants and the report but do not contribute to the root cause.As of the date of this medical investigation, there were no clinical factors found which would have contributed to the reported adverse event.It has not been confirmed whether the revision surgery has been scheduled or performed.The impact to the patient is the reported externally rotated leg and the pending revision as the patient's current condition is unknown and no further information is available.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, and prior actions could not be performed.A review of instructions for use for cadence total ankle system revealed in precautions that the patient should be aware of the possible risks, precautions, warnings, consequences, complications, and adverse reactions associated with the surgical procedure and implantation of the device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include, alignment, size selected and/or patient anatomy.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.

• Brand Name: UNKN CADENCE IMPL
• 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: 18378157
• MDR Text Key: 331184802
• Report Number: 3002788818-2023-00112
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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: Lay User/Patient
• Device Catalogue Number: UNKN2400104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female