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

Model Number	400-263
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.
Event or Problem Description
Subject had osteophytes which caused medial impingement.Subject had osteophytes removed on (b)(6) 2018 in which the ae resolved.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿reported device related adverse effects: the most commonly reported adverse effects associated with the star ankle are the following: pain and nerve injury, mobile bearing fracture, device loosening (tibial plate, talar component), instability, device subsidence.Potential adverse effects: the following adverse effects may occur in association with total ankle replacement surgery including the star ankle: device failure, dislocation, loosening of any of the components, fatigue fracture of the implants, heterotopic bone formation, adverse effects may necessitate reoperation, revision, arthrodesis of the involved ankle, and/or amputation of the ankle, increased ankle pain and/or reduced ankle function.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
Subject had osteophytes which caused medial impingement.Subject had osteophytes removed on (b)(6) 2018 in which the ae resolved.

• Brand Name: TIBIAL COMP,SINGLECOATED US VERSION, LARGE
• Common Device Name: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10892012
• Report Number: 0008031020-2020-02524
• Device Sequence Number: 11536991
• Product Code: NTG
• UDI-Device Identifier: 00886385016542
• UDI-Public: 00886385016542
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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 Model Number: 400-263
• Device Catalogue Number: 400263
• Device Lot Number: 1446086
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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: 58 YR
• Patient Weight: 102