TM SEGMENTAL COLLAR

MDR report key: 2452945 · Received February 10, 2012

Report

Report Number: 3005751028-2012-00024
Event Type: Injury
Date Received: February 10, 2012
Date of Event: January 17, 2012
Report Date: February 10, 2012
Manufacturer: ZIMMER TMT
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION IN PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PT HAD A GCT ON HIS RIGHT DISTAL FEMUR AND THE SURGEON DID A WIDE EXCISION AND MEGA IMPLANTATION. ZSS DISTAL IMPLANT WAS USED ON (B)(6) 2011. AFTERWARD, THE PT PRESENTED WITH A HYPEREXTENSION AND IT WAS FOUND THAT THE POLY INSERT WAS NOT ASSEMBLED PROPERLY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2012 TO CORRECT THE ISSUE. DURING THE SURGERY, THE SURGEON OBSERVED SOME METAL DEBRIS WHICH WAS REMOVED AND LAVAGED. IT WAS ALSO NOTED THAT THE PT HAD OSTEOLYSIS IN SURROUNDING BONE. THE SURGEON CONFIRMED THAT THE PT HAD GOOD FIXATION IN THE TIBIAL BASEPLATE AND STEM EXTENSION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TM SEGMENTAL COLLAR	SEGMENTAL	JWH	ZIMMER TMT		61169731

Patients

Seq	Age	Sex	Outcome	Treatment
1	27 YR		Required Intervention