MAUDE Adverse Event Report: INBONE TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ankylosis (4527)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

Device not returned at the time of this report as it remains implanted.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient underwent a total ankle replacement surgical procedure.The surgeon is doing a gutter debridement surgery and has requested new implants if needed as a backup plan.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation.And no other evidences were provided.Radiographic images provided were not of sufficient quality for a conclusion to be made.In general, gutter cleaning is additional surgery, which is performed quite regularly after tar (with all devices).It is associated with the procedure for sure, not necessarily related to the device used.More detailed information about the complaint event as well as the affected device must be available in order to determine, the root cause of the complaint event.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.A review of the device history was not possible, because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported, that the patient underwent a total ankle replacement surgical procedure.The surgeon is doing a gutter debridement surgery.And has requested, new implants if needed as a backup plan.

• Brand Name: INBONE TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• MDR Report Key: 12055449
• MDR Text Key: 258039514
• Report Number: 0001043534-2021-00113
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention