FDA Adverse Event Injury Summary report: N

BIOMET TIB BLOCK 6MM 79

MDR report key: 3000316 · Received March 12, 2013

Report

Report Number: 0001825034-2013-00572
Event Type: Injury
Date Received: March 12, 2013
Date of Event: February 12, 2013
Report Date: February 13, 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: WA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. THE COMPLAINT PARTS SHOW CHARACTERISTICS CONSISTENT WITH CROSS THREADED SCREWS. THE USER MUST TAKE CAUTION NOT TO CROSS THREAD THE SCREWS WHEN STARTING THE SCREWS INTO THE AUGMENTS. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00572-1 / 00573-1).

Additional Manufacturer Narrative · 1

EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00572 / 00573).

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE REVISION OF COMPETITOR PRODUCTS ON (B)(6) 2013. DURING THE PROCEDURE, THE SCREWS ON THE TIBIAL BLOCKS, WOULD NOT ADVANCE CORRECTLY. AFTER SCREWS WERE SEATED, THE AUGMENTS WOULD NOT SIT FLUSH WITH THE PLATE. THE SURGEON ATTEMPTED TO REMOVE THE SCREWS BUT ONE WAS COLD WELDED AND REMOVED WITH DIFFICULTY AND THE OTHER SCREW WAS STRIPPED. AS A RESULT, THERE WAS A DELAY GREATER THAN ONE HOUR TO THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
103612	BIOMET TIB BLOCK 6MM 79	PROSTHESIS, KNEE	JWH	BIOMET ORTHOPEDICS	N/A	245240

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R