FDA Adverse Event Injury Summary report: N

TGS UKA SYSTEM

MDR report key: 3839063 · Received May 15, 2014

Report

Report Number: 3004594167-2014-00003
Event Type: Injury
Date Received: May 15, 2014
Date of Event: April 18, 2014
Report Date: May 15, 2014
Manufacturer: CAYENNE MEDICAL INC.
Product Code: HSX
PMA / PMN Number: K090024
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
289528	TGS UKA SYSTEM	UNICOMPARTMENTAL KNEE ARTHROPLASTY	HSX	CAYENNE MEDICAL INC.		1111002-A

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Hospitalization\| R