MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. CADENCE TIBIAL TRAY. SIZE 3X. RIGHT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	10207113
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	06/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H11:this complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alter the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that after an ankle surgery that had been performed on (b)(6) 2018, the clinical subject experienced a periprosthetic fracture around internal prosthetic right ankle on (b)(6) 2018.This adverse event was solved by a surgery on (b)(6) 2018 and medication.The current outcome of the subject is recovered/resolved.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device, could not be returned for evaluation, a device analysis could not be performed.The clinical/medical investigation concluded that a definitive clinical root cause of the reported adverse event could not be determined.According to the study form on february 6, 2018, the adverse event was managed with surgical intervention, physical therapy, and medication.As the instructions for use for the cadence total ankle does precaution.¿patients need to be informed regarding expectations pertaining to performance and limitations following surgery.The prosthesis does not replace normal bone, has a finite service life, and future revision surgeries may be necessary.¿ the reported outcome for the subject is recovered/resolved.Since it was reported that the adverse advent was resolved no further impact is anticipated.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for cadence total ankle system, implant reveals in the section post-operative care to void extreme motion in flexion-extension.Excessive physical activity and trauma affecting the operated extremity have been implicated in the premature failure of joint arthroplasty as a result of position change and/or fracture.A review of the risk management file 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 this product and event.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 patient bone quality, post-operative patient condition and/or surgical technique.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: CADENCE TIBIAL TRAY. SIZE 3X. RIGHT
• Common Device Name: 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 25024674
• Report Number: 3002788818-2026-00050
• Device Sequence Number: 13055311
• Product Code: HSN
• UDI-Device Identifier: 00885556852354
• UDI-Public: 885556852354
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 10207113
• Device Lot Number: QJ0754-G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/03/2026
• Date Device Manufactured: 01/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART#: 10209311, LOT#: PN6914-G.; PART#: 10209311, LOT#: PN6914-G.; PART#:10208103. LOT#: QJ0268.; PART#:10208103. LOT#: QJ0268.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male