FDA Adverse Event Injury Summary report: N

MAXIM DCM CONSTRAINED TIBIAL BEARING 16X71/75

MDR report key: 3013242 · Received March 20, 2013

Report

Report Number: 0001825034-2013-00670
Event Type: Injury
Date Received: March 20, 2013
Date of Event: February 26, 2013
Report Date: February 25, 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: MI, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS IT STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00666 / 00670).

Description of Event or Problem · 1

A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2001. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE MALROTATION OF THE FEMORAL COMPONENT ON (B)(6) 2003. THE BEARING AND LOCKING BAR WERE REVISED ON (B)(6) 2006 FOR AN UNKNOWN REASON. IN ADDITION, THE PATIENT HAD A THIRD REVISION ON (B)(6) 2013 DUE TO LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT. THE FEMORAL AND TIBIA COMPONENT WERE REMOVED AND REPLACED WITH COMPETITOR'S PRODUCT. IT IS UNKNOWN IF THE PATELLA COMPONENT WAS LOOSE OR REMOVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
115468	MAXIM DCM CONSTRAINED TIBIAL BEARING 16X71/75	PROSTHESIS, KNEE	JWH	BIOMET ORTHOPEDICS	N/A	807540

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Hospitalization\| R