MAUDE Adverse Event Report: CAYENNE MEDICAL, INC. TGS UKA FEMORAL - 50MM; UNICOMPARTMENTAL KNEE ARTHROPLASTY

Catalog Number 100281

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

Patient Problem Arthralgia (2355)

Event Date 02/28/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the mfr was informed that a pt with a tgs uka implant had been seen arthroscopically due to persistent pain.The pt underwent a revision on (b)(6) 2014 to convert to a total knee arthroplasty (tka).Upon conversation with the surgeon about the case, it was found that the femoral implant was loose at the time of conversion.The results of investigation concluded that there is no evidence reasonably suggesting that the tgs femoral implant was the cause for the conversion to a total knee replacement.

Manufacturer Narrative

Product was not returned for eval.There was no evidence suggesting any product/ system failure, and the need for corrective action is not indicated.

• Brand Name: TGS UKA FEMORAL - 50MM
• 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: 3733087
• MDR Text Key: 18922263
• Report Number: 3004594167-2014-00002
• 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: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2012
• Device Catalogue Number: 100281
• Device Lot Number: 0911004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2010
• 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: 60 YR