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

Model Number	10207102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Impingement (4834)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a total ankle arthroplasty surgery (right) which had been performed on (b)(6) 2018, the patient experienced, on (b)(6) 2022, anteromedial impingement syndrome, with ongoing pain of the antero- and postmedial right ankle, and additional adherences of the tibialis posterior tendon.This adverse event was treated with an arthroscopy of the right ankle and a adhesiolysis of the tibialis posterior tendon, which were carried out on (b)(6) 2022.As a result of this treatment, the adverse event was reported as resolved without sequelae on (b)(6) 2023.There was a previous incidence of anteromedial impingement syndrome that the patient had experienced on (b)(6) 2018.This was resolved via arthroscopy and considered unrelated to the second adverse event by the hcp, documented as resolved on (b)(6) 2019.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: additional information was added in section b7.
Additional Manufacturer Narrative
H11: corrected information on d4 (lot number of the device).
Event or Problem Description
It was reported that, after a total ankle arthroplasty surgery (right) which had been performed on (b)(6) 2018, the patient experienced, on (b)(6) 2022, anteromedial impingement syndrome, with ongoing pain of the antero- and postmedial right ankle, and additional adherences of the tibialis posterior tendon.This adverse event was treated with an arthroscopy of the right ankle and a adhesiolysis of the tibialis posterior tendon, which were carried out on (b)(6) 2022.As a result of this treatment, the adverse event was reported as resolved without sequelae on (b)(6) 2023.There was a previous adverse event that the patient had experienced; pain, on (b)(6) 2018.This was resolved via arthroscopy, nothing of note was found, and was considered unrelated to the second adverse event by the hcp; documented as resolved on 23-apr-2019.
Additional Manufacturer Narrative
Results of investigation: the product has not been received at the aus site for evaluation and photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified similar reported events for this device.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.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.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.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: no further insight into the reported issue of ¿anteromedial impingement syndrome¿ with ongoing pain could be made.Patient impact beyond the reported symptoms and additional surgery is not anticipated, as it has been reported that the adverse event was ¿resolved without sequelae¿ after treatment.Visual inspection: visual inspection was unable to be performed because the device has not been received for evaluation.The complaint alleges that revision surgery was required.As the product has not been received for evaluation, it could not be determined whether the device contributed to the reported event.As the product has not been received for evaluation, a definitive root cause for the reported event could not be determined.The tibial tray is one of three sterile, implantable components comprising the cadence total ankle system.The complaint alleges that the patient experienced impingement and pain several years after the implantation of the cadence total ankle system and was successfully treated with revision surgery.According to risk documentation for the cadence system, a potential cause for the reported event included incorrect surgical technique.Based on this investigation, the need for corrective action is not indicated as no non-conformances or manufacturing 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.

• Brand Name: CADENCE TIBIAL TRAY. 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: 16764232
• Report Number: 3002788818-2023-00029
• Device Sequence Number: 3037560
• Product Code: HSN
• UDI-Device Identifier: 00885556852293
• UDI-Public: 00885556852293
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/06/2023

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: 10207102
• Device Catalogue Number: 10207102
• Device Lot Number: QJ0227-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: 03/23/2023
• Supplement Date Received by Manufacturer: 04/17/2023; 05/22/2023; 06/05/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 04/26/2023; 05/22/2023; 06/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 10208101 / LOT: QJ0329-G.; PN: 10209106 / LOT: 172967-G.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 70 KG