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

Model Number	10208102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Date of Event	05/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, 1.5 years after total ankle surgery, the cadence talar dome.Size 2.Right had broken pegs.The patient experiences pain and describes an important decrease in his quality of life.It is unknown if/how this adverse event was treated.Patient's current health status is unknown.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information confirmed that this event is a duplicate of the report number: 3002788818-2022-00038 (our reference number: (b)(4).Therefore, the event will be covered under the aforementioned report number.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal complaint reference number: (b)(4) additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information confirmed that this event is a duplicate of the report number 3002788818-2022-00038 (our reference number: (b)(4).Therefore, the event will be covered under the aforementioned report number.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: CADENCE TALAR DOME. SIZE 2. 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: 14711075
• Report Number: 3002788818-2022-00037
• Device Sequence Number: 5300435
• Product Code: HSN
• UDI-Device Identifier: 10381780239321
• UDI-Public: 10381780239321
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K151459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10208102
• Device Catalogue Number: 10208102
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown