MAUDE MDR 3300755

MDR report key: 3300755
Report number: 1822565-2013-01239
Event key: 0
Event type: 3
Date of event: 2013-07-17
Date received: 2013-08-15
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: KEVIN ESCAPULE
Address: P. O. BOX 708 WARSAW IN 46581 US
Phone: 800-800-8006
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	VERSYS PROVISIONAL FEMORAL HEAD		ZIMMER, INC.	HSA		00789503602					R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2013-08-15	0

Event Narratives#

D

Patient 1

IT IS REPORTED THAT THE SURGEON REDUCED THE JOINT WITH A TRIAL HEAD. THE SURGEON THEN TRIED TO REMOVE THE TRIAL AND IT WAS DISCOVERED THAT THE HEAD WAS JAMMED ON THE STEM TRUNNION. UPON TRYING TO REMOVE THE HEAD, THE STEM WAS LOOSENED IN THE CEMENT MANTLE BECAUSE THE HEAD GRIPPED THE TRUNNION SO STRONGLY. THE STEM WAS REMOVED AND A NEW STEM WAS PLACED. A DIFFERENT TRIAL HEAD ALSO STUCK TO THIS STEM, BUT WAS ABLE TO BE TAPPED OFF.

N