MAUDE Adverse Event Report: STRYKER GMBH TIBIAL COMP,SINGLECOATED US VERSION, SMALL; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400261

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "failure of right ankle joint replacement." patient experienced pain.Revision surgery occurred as a result.

Event Description

As reported: "failure of right ankle joint replacement." patient experienced pain.Revision surgery occurred as a result.

Manufacturer Narrative

The reported event could not be confirmed.Device evaluation: the tibial & talar components have been returned with bits of bones attached to it, which confirms that osseointegration has been achieved.The device itself does not show any traces of deformation of the material or major scratches or breakage.Some scratches can be noticed on the sides of the device, but nothing that could compromise its functionality.The x-rays having been provided, the opinion of a medical expert has been requested.Their statement is as follows: ¿[¿] it seems as if there is loosening of the tibial component.From the given ap-view one could assume, that a little bit of lateral settling of the component also has taken place.There are also some cysts to be guessed at the lateral part of the tibial component.I would recommend further investigations maybe including a puncture and a scintigraphy.[¿]¿ as a conclusion, the loosening of the tibial component as well as the potential presence of some cysts could be considered as the root cause of the pain that the patient underwent.Based on the available information a deficiency of the devices in question could be discarded.In case any relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.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: TIBIAL COMP,SINGLECOATED US VERSION, SMALL
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9288584
• MDR Text Key: 178369660
• Report Number: 0008031020-2019-01595
• 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: other
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 400261
• Device Lot Number: 091119/3464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR