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 Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Patient presented with pain.X-ray of talus showed tipped backwards and some collapse.

Event Description

Patient presented with pain.X-ray of talus showed tipped backwards and some collapse.

Manufacturer Narrative

The reported event that talar comp,single coated us version small, right was alleged of 'implant - loose' could be confirmed.The device inspection revealed the following: the pe sliding core shows various signs of wear, such that it is chipped on one of its corners.This was likely produced during explantation.The tibial- as well as the talar components showed signs of use in the form of scratches, and some bone and blood residues, but no significant damage.Furthermore, all the components show some kind of oily brown body fluid that could not be identified from the pictures alone.Overall the results of the stage 1 analysis are consistent with well-positioned and well-functioning devices implanted for approximately 6 years.A clinical statement was requested from our clinical expert regarding this case.Their statement says: " it is obvious to see the tilt of the talar component is posterior bound, but what is concerning, and not related to the implant, is the obvious surgical cut in the anterior neck of the talus, it looks a though the original position of talar component implantation was off its mark.Again, it would be beneficial to see the pre-op and immediate post-op film.In reviewing the photos of the implant, all looks quite intact, with no flaws in the components or poly, over the past 6 years.Conclusion: i believe this is not implant related but rather attributed to the fact that this implant was inserted into a non-united tibiotalar arthrodesis.The articular surfaces would have be removed and more bone resected for the non-union, this would negate any possibility of following the appropriate methods and indications of star implantation." as a conclusion, the event reported is not implant related.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.

• 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: 7539084
• MDR Text Key: 109101079
• Report Number: 0008031020-2018-00391
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 118