MAUDE Adverse Event Report: STRYKER GMBH TALAR COMP,SINGLE COATED US VERSION SMALL, RIGHT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400254

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 01/02/2019

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The hospital disposed of the item.

Event Description

Today at st.Vincent healthcare we had a case in which we revised a previous star total ankle arthroplasty.Dr.Was the surgeon and told me before the case started that he would like to just pull the talar component and poly insert and then replace both of them with likely the same size, possibly a size smaller.He said that he suspects the talar component to be loose after viewing it before the operation in x-ray.The talar component was loose and he pulled it out and made a comment about how he saw no bony in-growth on the implant.We made a few adjustments and put in two new implants and the case went fairly smoothly, i just wanted to make sure to report his observation that there was virtually no bony in-growth on the talar component he removed.The issue was noticed during the operation when the surgeon removed the previously implanted talar component.

Event Description

Today at (b)(6) we had a case in which we revised a previous star total ankle arthroplasty.Dr.Was the surgeon and told me before the case started that he would like to just pull the talar component and poly insert and then replace both of them with likely the same size, possibly a size smaller.He said that he suspects the talar component to be loose after viewing it before the operation in x-ray.The talar component was loose and he pulled it out and made a comment about how he saw no bony in-growth on the implant.We made a few adjustments and put in two new implants and the case went fairly smoothly, i just wanted to make sure to report his observation that there was virtually no bony in-growth on the talar component he removed.The issue was noticed during the operation when the surgeon removed the previously implanted talar component.

Manufacturer Narrative

The reported event that talar comp, single coated us version small, right was alleged of 'implant - loose' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event such as x-rays, patient info as well as the affected device must be available in order to determine the root cause of the complaint event.However, the opinion of one of stryker's medical experts was requested as to why no bone in growth was noticed.Their general statement says: ingrowth would be the optimum in total joint replacement.But it is dependent on several factors, besides prevention of (sub clinical) infection.Important is a very good initial stability.The ankle is the most loaded joint in the body and due to its shape initial stability is difficult to achieve.If it is not achieved, you will have micro motions.When micro motions occur there will be no bony in growth.The body will try to stabilize the situation with the development of very stiff and stable connective scar tissue.This is a general statement that could be applied to cases where no bone in growth can be noticed.As more specific evaluation is only possible if pre- and post- operative x-rays can be provided.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TALAR COMP,SINGLE COATED US VERSION SMALL, RIGHT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8283518
• MDR Text Key: 134314538
• Report Number: 0008031020-2019-00050
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385016450
• UDI-Public: 00886385016450
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 400254
• Device Lot Number: 1451099
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR