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); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	05/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, 1.5 years after total ankle surgery was performed on (b)(6) 2020, 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
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
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.Refer to the respective tasks for further detail.Complaint history review: the complaint history review identified previous similar reported events for this device, but not 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.Medical investigation monitoring board (mimb) review: per mimb, a medical investigation was required.Clinical/medical evaluation: definitive root cause could not be determined, but possible micro- motion and the patient¿s underlying diagnosis of hemochromatosis noted by customer cannot be ruled out as contributing factors to the reported symptoms.The complaint alleges injury to the patient requiring professional medical intervention beyond the standard-of-care.It could not be determined whether the device contributed to the reported event.According to risk management documentation for the cadence total ankle system, there are several identified failure modes which could result in breakage of the talar dome, including incorrect patient selection and incorrect or inadequate surgical technique.The clinical/medical evaluation identified possible micro-motion and the patient¿s underlying diagnosis of hemochromatosis as potential contributing causes.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.This investigation can be closed.
Additional Manufacturer Narrative
H3, h6: 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.Refer to the respective tasks for further detail.Complaint history review: the complaint history review identified previous similar reported events for this device, but not 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.Medical investigation monitoring board (mimb) review: per mimb, a medical investigation was required.Clinical/medical evaluation: definitive root cause could not be determined, but possible micro- motion and the patient¿s underlying diagnosis of hemochromatosis noted by customer cannot be ruled out as contributing factors to the reported symptoms.The complaint alleges injury to the patient requiring professional medical intervention beyond the standard-of-care.It could not be determined whether the device contributed to the reported event.According to risk management documentation for the cadence total ankle system, there are several identified failure modes which could result in breakage of the talar dome, including incorrect patient selection, inadequate design, and incorrect or inadequate surgical technique.The clinical/medical evaluation identified possible micro- motion and the patient¿s underlying diagnosis of hemochromatosis as potential contributing causes.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.This investigation can be closed.
Additional Manufacturer Narrative
Sections a4, b5, b7, d4 and h4 were updated according to the new information received.Internal complaint reference number: (b)(4) section d4 and h6 were corrected according to the new information received.
Event or Problem Description
It was reported that, 1.5 years after total ankle surgery was performed on (b)(6) 2020, the cadence talar dome.Size 2.Right had broken pegs.The patient experiences pain and swelling, 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
Section d10 was updated.Internal complaint reference number: (b)(4).Section h6 (health effect) was corrected.

• 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: 14742812
• Report Number: 3002788818-2022-00038
• Device Sequence Number: 17509121
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/09/2022

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: 07/31/2021
• Device Model Number: 10208102
• Device Catalogue Number: 10208102
• Device Lot Number: 172703
• 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: 06/27/2022; 07/13/2022; 07/31/2022; 07/31/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 07/05/2022; 07/14/2022; 08/24/2022; 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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: 10207112/QJ0752-G/CADENCE TIBIAL TRAY SIZE 2XRIGHT; 10209206/PN6900-G/CADENCE INSERT SZ2 RT6MM NEUTRAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 80 KG