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

Catalog Number	400264
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Still implanted in patient.
Event or Problem Description
Subject received a star in the right ankle on (b)(6) 2017.On (b)(6) 2019, subject shows slight lucency above lateral barrel on tibia.No action has been taken; the subject is continuing without treatment.This event does not involve death, serious injury, or medical intervention.
Additional Manufacturer Narrative
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 as well as the affected device and medical records must be available in order to determine the root cause of the complaint event.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.A review of the labeling did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.Based on the above information, a deficiency of the devices in questions was not verified.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Subject received a star in the right ankle on (b)(6)2017.On (b)(6)2019, subject shows slight lucency above lateral barrel on tibia.No action has been taken; the subject is continuing without treatment.This event does not involve death, serious injury, or medical intervention.

• 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: 8625521
• Report Number: 0008031020-2019-00508
• Device Sequence Number: 1876201
• Product Code: NTG
• UDI-Device Identifier: 00886385016559
• UDI-Public: 00886385016559
• 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): 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 400264
• Device Lot Number: 1445098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 113