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

Model Number	10207203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a cadence total ankle surgery was performed on (b)(6) 2022, on 5-may-2022 the patient suffered a fall, on (b)(6) 2022 x-ray confirmed a non displaced medial malleolus fracture.This will be treated with 6 weeks of plastercast below the knee.Patient is fine and has a visit on (b)(6) 2022.
Additional Manufacturer Narrative
Section h10: the product has not been received at the aus site for evaluation and photographs were not provided, so the complaint could not be confirmed.The following investigative actions were performed: complaint history review: the complaint history review identified no similar reported events for this device nor for the same product lot.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.Dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Clinical/medical evaluation: determined that the root cause for the reported event was most likely the traumatic fall experienced by the patient.The complaint alleges an injury to the patient requiring professional medical intervention beyond the standard-of-care.It was determined that the device likely did not contribute to the reported event.The complaint description indicates that the patient experienced a traumatic fall several days after the implantation surgery, after which it was identified that the medial malleolus was fractured.The most likely cause for the bone fracture was trauma experienced during the fall.Based on this investigation, the need for corrective action is not indicated as no non-conformances or product deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.Internal complaint reference number: (b)(4).Section h6 (health effect) was corrected.

• Brand Name: CADENCE TIBIAL TRAY. SIZE 3. LEFT
• 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: 14627044
• Report Number: 3002788818-2022-00035
• Device Sequence Number: 17050305
• Product Code: HSN
• UDI-Device Identifier: 10381780239246
• UDI-Public: 10381780239246
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K151459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/05/2022

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 Expiration Date: 03/03/2022
• Device Model Number: 10207203
• Device Catalogue Number: 10207203
• Device Lot Number: 181319G
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2018
• 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: HYDROCORTISON 20MG TABLET.; LEVOTHYROXINE (THYRAX) 150UG.; TESTOSTERON.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 86 KG