MAUDE Adverse Event Report: STRYKER GMBH TALAR COMP,SINGLE COATED US VERS X-SMALL, RIGHT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Model Number 400-252

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

Patient Problem Implant Pain (4561)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "ankle pain.Explantation of star total ankle and revision to ttc.".

Manufacturer Narrative

The reported event could be confirmed.The devices were returned and do not show any major deformation, even following 5 years of implantation.The polyethylene component does not show any major signs of deformation on the plastic, and the metallic parts still have remains of bone and tissues, which proves a proper osseointegration of the implant with the bone.Since x-rays were provided for this case, the opinion of a medical expert was requested and states: "[.] the patient in question received an ankle prosthesis in 2015 which was revised in 2020.Looking at the available info from the post-operative follow up in the outpatient department and the additional x-rays the problem lies in the talus.Either cystic changes or avascular necrosis might cause the collapse of the talar bone.The current condition of the talar bone can most certainly explain the pain of the patient.Unfortunately we cannot compare the pictures with the ones from 2015 and we do did not see the ct-scan, but as mentioned the current condition of the talus in combination with the patients complaints do justify a reoperation.It is up to the surgeon and the patient to discuss the options which in this case led to an arthrodesis.[.]" based on this statement, the root cause can be attributed to a patient related factor, that resulted in complications at the talus level.A review of the device history for the reported lot did not indicate any abnormalities.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 any further information is provided, the investigation report will be updated.

Event Description

As reported: "ankle pain.Explantation of star total ankle and revision to ttc.".

• Brand Name: TALAR COMP,SINGLE COATED US VERS X-SMALL, RIGHT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10805483
• MDR Text Key: 216416804
• Report Number: 0008031020-2020-02429
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385016436
• UDI-Public: 00886385016436
• Combination Product (y/n): N
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

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 Expiration Date: 08/31/2019
• Device Model Number: 400-252
• Device Catalogue Number: 400252
• Device Lot Number: 1424110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 70