MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE, UHMPWE,9MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Model Number	400-143F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/12/2020
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
As reported; "ankle pain.Explantation of star total ankle and revision to ttc.".
Additional Manufacturer Narrative
The reported event be confirmed.The devices were returned and do not show any major deformation, even following 5 years of implantation.The polyethylene component does not show any major signs of deformation on the plastic, and the metallic parts still have remains of bone and tissues, which proves a proper osseointegration of the implant with the bone.Since x-rays were provided for this case, the opinion of a medical expert was requested and states: "[.] the patient in question received an ankle prosthesis in 2015 which was revised in 2020.Looking at the available info from the post-operative follow up in the outpatient department and the additional x-rays the problem lies in the talus.Either cystic changes or avascular necrosis might cause the collapse of the talar bone.The current condition of the talar bone can most certainly explain the pain of the patient.Unfortunately we cannot compare the pictures with the ones from 2015 and we do did not see the ct-scan, but as mentioned the current condition of the talus in combination with the patients complaints do justify a reoperation.It is up to the surgeon and the patient to discuss the options which in this case led to an arthrodesis.[.]" based on this statement, the root cause can be attributed to a patient related factor, that resulted in complications at the talus level.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.
Event or Problem Description
As reported; "ankle pain.Explantation of star total ankle and revision to ttc.".

• Brand Name: SLIDING CORE, UHMPWE,9MM
• Common Device Name: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10805484
• Report Number: 0008031020-2020-02427
• Device Sequence Number: 3570405
• Product Code: NTG
• UDI-Device Identifier: 00886385026954
• UDI-Public: 00886385026954
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Model Number: 400-143F
• Device Catalogue Number: 400143F
• Device Lot Number: 1437088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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
• Patient Age: 63 YR
• Patient Weight: 70