MAUDE Adverse Event Report: STELKAST INC. UNICONDYLAR KNEE SYSTEM; INLAY TIBIAL COMPONENT

Model Number SC3405-5X-6

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/06/2016

Event Type  No Answer Provided  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient revised due to infection.

• Brand Name: UNICONDYLAR KNEE SYSTEM
• Type of Device: INLAY TIBIAL COMPONENT
• Manufacturer (Section D): STELKAST INC.; 200 hidden valley road; mcmurray PA 15317
• Manufacturer (Section G): STELKAST INC.; 200 hidden valley road; mcmurray PA 15317
• Manufacturer Contact: john reyher ; 200 hidden valley road; mcmurray, PA 15317 ; 7249416368
• MDR Report Key: 5978280
• MDR Text Key: 55667734
• Report Number: 2530191-2016-00110
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/26/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Model Number: SC3405-5X-6
• Device Lot Number: 31208-42114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR