MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE TIBIAL TRAY, SIZE 1X, RIGHT; CADENCE TOTAL ANKLE SYSTEM

Catalog Number 10207111

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

The cadence tibial tray was implanted on (b)(6) 2019 with no postoperative complications.A follow up x-ray showed the lateral peg of the tibial component was broken, causing loosening and shift of the implant.On (b)(6) 2019 a total ankle arthroplasty was performed to remove the product.

Event Description

N/a.

Manufacturer Narrative

The device was returned for evaluation.Dhr - a review of the lot records was conducted and there were no indications of problems that could have caused or contributed to the complaint.Failure analysis determined that the lateral peg of the implant was more strongly fixated than the rest of the implant.This difference in fixation caused the lateral peg to be loaded in bending, resulting in the fracture.Root cause - the insufficient fixation of the implant lead to fatigue failure of the lateral peg.There was one 10207111 cadence tibial tray, size 1x, right returned with the complaint that the lateral peg of the tibial component broke, caused loosening and shift of the implant.The failure was confirmed.A review of the lot records was conducted and there were no indications of problems that could have caused or contributed to the complaint.The product development engineer concluded that the implant had insufficient fixation, leading to fatigue failure of the lateral peg.Between (b)(6) 2019 and (b)(6) 2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period (b)(6) 2019 through (b)(6) 2020.Integra lifesciences contacted (b)(6) , director of regulatory programs, office of product evaluation and quality and (b)(6) , assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: CADENCE TIBIAL TRAY, SIZE 1X, RIGHT
• Type of Device: CADENCE TOTAL ANKLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• MDR Report Key: 10277543
• MDR Text Key: 206773033
• Report Number: 1651501-2020-00002
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K151459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10207111
• Device Lot Number: 173546G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1