MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. CADENCE TIBIAL TRAY. SIZE 2X. RIGHT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	10207112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pain (1994); Impaired Healing (2378); Medical device site infection (4845)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: h5, h6 (health effect - clinical code, health effect - impact code and type of investigation), h10 (roi).H10: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that it is noted the patient¿s infected total ankle replacement and significant wound breakdown was due to high dose of intravenous steroids that led to the subsequent revision.Although the patient¿s history of multiple ankle surgeries and the use of flonase could not be rule out as likely contributing factors.Therefore, the causal relationship between the reported adverse events and the smith and nephew device could not be established.The impact to the patient beyond the reported revision could not be determined since the patient¿s outcome is unknown.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 for the part numbers over the past 12 months and for the batch numbers 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 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.Infection has been identified as an adverse event.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 these products and event.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices or 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.H6 (health effect - clinical code and health effect - impact code).
Additional Manufacturer Narrative
D1, d4: corrected.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: 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 alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that after undergoing a tar on (b)(6) 2018, patient experienced infected tar and significant wound breakdown due to high dose iv steroids.After this, he had severe corp exacerbation.This adverse event was addressed by performing a revision surgery on (b)(6) 2019, during which a washout along with a spacer placement was done.Patient's current health status is unknown.
Additional Manufacturer Narrative
Additional information: d10, h10 (roi).H10: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that it is noted the patient¿s infected total ankle replacement and significant wound breakdown was due to high dose of intravenous steroids that led to the subsequent revision.Although the patient¿s history of multiple ankle surgeries and the use of flonase could not be rule out as likely contributing factors.Therefore, the causal relationship between the reported adverse events and the smith and nephew device could not be established.Additional factors that could contribute to the reported event include, post-operative healing issue, injury, patient condition and/or medical history.Further impact to the patient is not anticipated as the outcome was reported as resolved without sequelae.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 for the part numbers over the past 12 months and for the batch numbers 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 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.Infection has been identified as an adverse event.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 these products and event.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the devices or 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.Internal complaint reference: (b)(4).

• Brand Name: CADENCE TIBIAL TRAY. SIZE 2X. 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20824986
• Report Number: 3002788818-2024-00126
• Device Sequence Number: 21065037
• Product Code: HSN
• UDI-Device Identifier: 00885556852347
• UDI-Public: 885556852347
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• 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,Followup,Followup
• Report Date (Section B): 03/26/2025

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: 03/03/2021
• Device Catalogue Number: 10207112
• Device Lot Number: QJ0752-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: 11/11/2024
• Supplement Date Received by Manufacturer: Not provided; 01/17/2025; 03/19/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/07/2025; 01/20/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2016
• 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: 10208101, CADENCE TALAR DOME. SIZE 1. RIGHT; 10209106, CADENCE INSERT SZ1 RT 6MM NEUTRAL; CADENCE TALAR DOME. SZ 1. RT: 10208101, 180585G; CADENCE TIBIAL TRY. SZ 2X. RT: 10207112, QJ0752-G
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 100 KG