MAUDE Adverse Event Report: STRYKER GMBH TIBIAL COMP,SINGLECOATED US VERS, X-LARGE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number	400264
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that, during a star total ankle revision to do a poly component swap, once exposure was made, the tibial component was broken.Tibial component was replaced and poly was exchanged.Because the tibial component was broken, the case time was increased to replace component.
Additional Manufacturer Narrative
Correction: sections concomitant medical products and device evaluated by mfr.The reported event 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 pre- and post- operative x-rays, as well as the affected device, or at least a description of how the device broke must be available in order to determine the root cause of the complaint event.However, based on complaint history review, some potential root causes are: - fatigue & wear of the material.It is clearly stated in the ifu to: "warn the patient that artificial joint replacement devices can wear out over time, and may require replacement." - the selection of improper size of the device during first implantation and/or improper placement of the device.As a reminder, the ifu states: "improper selection, placement and fixation of the implant components may result in early implant failure.As in the case of all prosthetic implants, the durability of these components is affected by numerous biologic, biomechanic and other extrinsic factors which limit their service life.Accordingly, strict adherence to the indications, contraindications, precautions and warnings for this product is essential to potentially maximize service life." - the subjection of the implant to high impact shocks.It is written in the ifu to: "caution the patient to protect the joint replacement from unreasonable stresses and to follow the treating physician¿s instructions.In particular, warn the patient to strictly avoid high impact activities such as running and jumping." 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 or Problem Description
It was reported that, during a star total ankle revision to do a poly component swap, once exposure was made, the tibial component was broken.Tibial component was replaced and poly was exchanged.Because the tibial component was broken, the case time was increased to replace component.
Event or Problem Description
It was reported that, during a star total ankle revision to do a poly component swap, once exposure was made, the tibial component was broken.Tibial component was replaced and poly was exchanged.Because the tibial component was broken, the case time was increased to replace component.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matched the failure mode reported.The pictures that were provided for this case show that the tibial component is indeed broken in two pieces at the level of the frontal medial corner.The pictures and the x-rays provided were reviewed.As a conclusion, potential root causes could be, but are not limited to (and could not be confirmed by the x-rays): some repetitive contact between the tibial and talar component, which could have caused the fatigue of the metal.A potential luxation between the anterior tibial metal component and the distal structures, which could have caused important forces that would have broken the implant.In this regard, it is clearly stated in the ifu that: "warn the patient that artificial joint replacement devices can wear out over time, and may require replacement." 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 complaint report will be updated.

• Brand Name: TIBIAL COMP,SINGLECOATED US VERS, X-LARGE
• Common Device Name: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8537094
• Report Number: 0008031020-2019-00368
• Device Sequence Number: 16243317
• Product Code: NTG
• UDI-Device Identifier: 00886385016559
• UDI-Public: 00886385016559
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 400264
• Device Lot Number: 130514/1645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/25/2019; 07/22/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/17/2019; 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention