FDA Adverse Event Injury Summary report: N

BIOMET CC I-BEAM TRAY 75MM W/ LOCKING BAR

MDR report key: 3243725 · Received July 23, 2013

Report

Report Number: 0001825034-2013-02857
Event Type: Injury
Date Received: July 23, 2013
Date of Event: July 9, 2013
Report Date: June 24, 2013
Manufacturer: BIOMET ORTHOPEDICS
Product Code: JWH
PMA / PMN Number: PK915132
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 3 STATES, "THE LOCKING BAR USED TO SECURE THE TIBIAL PLATE AND TIBIAL-BEARING COMPONENTS TOGETHER MUST LOCK SECURELY INTO PLACE WITH AN AUDIBLE CLICK AT THE TIME OF IMPLANTATION. DISASSOCIATION OF THE LOCKING BAR FROM THE MODULAR TIBIAL PLATE COMPONENT HAS BEEN REPORTED. INADEQUATE SEATING OF THE LOCKING BAR CAN CAUSE DISASSOCIATION OF THE LOCKING BAR FROM THE TIBIAL PLATE COMPONENT, REQUIRING REVISION SURGERY." DATE EXPLANTED - ONLY THE LOCKING BAR PORTION OF THE TIBIAL TRAY WAS REMOVED AND REPLACED. THE TIBIAL TRAY WAS NOT REPORTED TO HAVE BEEN REMOVED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(4) 2013, DUE TO THE LOCKING BAR BACKING OUT. THE LOCKING BAR WAS REMOVED AND REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
342238	BIOMET CC I-BEAM TRAY 75MM W/ LOCKING BAR	PROSTHESIS, HIP	JWH	BIOMET ORTHOPEDICS	N/A	J2483549

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R