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

Catalog Number 400259

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

Patient Problem Implant Pain (4561)

Event Date 01/01/2020

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

As reported: "patient stated, in (b)(6) 2011 he had left ankle surgery.Early this year he started to experience pain usually after a long walk, sitting down for long periods of time, and as soon as he wakes up.".

Manufacturer Narrative

The reported event could be confirmed, only based on x-rays.Since post operative x-rays dating from 2016 were provided, the opinion of a medical expert was requested, and states: "[.] the patient had surgery in 2011.[.] to judge the case based on x-rays from 2016 is difficult.First the x-rays are not of high quality with regard to the technique.None of the pictures really show a proper view on the prosthesis and the joint.There may be signs of cyst formation in two of the three pictures.Furthermore it looks like the tibial component does not correctly fit, it looks like that on both ap views.It might be that the tibial cut is done too proximal, since it seems that the medial malleolus looks quite long, maybe this causes impingement complaints and pain.As said, these x-rays may not correspond to the current problems since they are 4 years old.[.]" as a summary, since the provided x-rays are 4 years old, no conclusion can be drawn for certain.Some more recent documents are the only way to determine the root cause of the pain reported by the patient.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

As reported: "patient stated, in january 2011 he had left ankle surgery.Early this year he started to experience pain usually after a long walk, sitting down for long periods of time, and as soon as he wakes up.".

Event Description

As reported: "patient stated, in (b)(6) 2011 he had left ankle surgery.Early this year he started to experience pain usually after a long walk, sitting down for long periods of time, and as soon as he wakes up.".

Manufacturer Narrative

The information on catalog number and lot number has been received.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.

• Brand Name: TALAR COMP,SINGLE COATED US VERS LARGE, LEFT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10838635
• MDR Text Key: 216414892
• Report Number: 0008031020-2020-02443
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2021

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 Catalogue Number: 400259
• Device Lot Number: 090319
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 01/05/2021; 04/06/2021
• Supplement Dates FDA Received: 01/21/2021; 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 104