MAUDE Adverse Event Report: CAYENNE MEDICAL INC. TGS UKA SYSTEM; UNICOMPARTMENTAL KNEE ARTHROPLASTY

Catalog Number 100416

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthralgia (2355)

Event Date 04/18/2014

Event Type  Injury  

Event Description

Cayenne medical was informed that a patient, who received a tgs uka (mirror) on (b)(6) 2013, twisted his knee in (b)(6) 2014 and consequently felt a sudden crack leading to pain and swelling.As a result, the surgeon performed a knee arthroscopy on (b)(6) 2014, and found the femoral component to be loose.The tibial component was found to be secure.The surgeon is planning to convert the partial knee to a total knee but the revision date is not known as of this date.

Manufacturer Narrative

510(k) number k090024.Covers initial release of tgs uka system including all instrumentation, femoral implants, and all-poly tibial implants.510(k) number 101206 covers the replacement of the all-poly tibial implants with tibial baseplate implants and tibial insert implants.Tibial baseplate: lot number 1103022-a, catalog number 100299, mfg date: 06/2011, exp.Date: 06/2014.Tibial insert: lot number 1103040-a, catalog number 100332, mfg date: 11/2011, exp.Date: 11/2014.Product was not returned for evaluation.Dhrs were reviewed and found to have no anomalies.There was no evidence suggesting any product/system failure, and the need for corrective action is not indicated.

• Brand Name: TGS UKA SYSTEM
• Type of Device: UNICOMPARTMENTAL KNEE ARTHROPLASTY
• Manufacturer (Section D): CAYENNE MEDICAL INC.; scottsdale AZ
• Manufacturer Contact: shima hashemian, sr. manager ; 16597 n. 92nd st.; suite 101; scottsdale, AZ 85260 ; 4805023661
• MDR Report Key: 3839063
• MDR Text Key: 4616126
• Report Number: 3004594167-2014-00003
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2014

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: Other
• Device Expiration Date: 05/01/2015
• Device Catalogue Number: 100416
• Device Lot Number: 1111002-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR