MAUDE Adverse Event Report: STRYKER GMBH TIBIAL COMP,SINGLECOATED US VERS, X-LARGE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Model Number 400-264

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

Patient Problem Implant Pain (4561)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

Subject had pain due to exostosis fibula/lateral gutter impingement (seen on x-ray) and had an exostectomy.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿reported device related adverse effects: the most commonly reported adverse effects associated with the star ankle are the following: pain and nerve injury, mobile bearing fracture, device loosening (tibial plate, talar component), instability, device subsidence.Potential adverse effects: the following adverse effects may occur in association with total ankle replacement surgery including the star ankle: device failure, dislocation, loosening of any of the components, fatigue fracture of the implants, heterotopic bone formation, adverse effects may necessitate reoperation, revision, arthrodesis of the involved ankle, and/or amputation of the ankle, increased ankle pain and/or reduced ankle function.¿ 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.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

Subject had pain due to exostosis fibula/lateral gutter impingement (seen on x-ray) and had an exostectomy.

• Brand Name: TIBIAL COMP,SINGLECOATED US VERS, X-LARGE
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10780894
• MDR Text Key: 216573725
• Report Number: 0008031020-2020-02421
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385016559
• UDI-Public: 00886385016559
• Combination Product (y/n): N
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400-264
• Device Catalogue Number: 400264
• Device Lot Number: 1450129
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 76