FDA Adverse Event Injury Summary report: N

M2A MAGNUM PF CUP 52MM OD X 46MM ID

MDR report key: 1981232 · Received February 8, 2011

Report

Report Number: 1825034-2011-00089
Event Type: Injury
Date Received: February 8, 2011
Date of Event: October 7, 2010
Report Date: January 14, 2011
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: K042037
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, 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: "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT FILED (B)(4), 2011.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 DUE TO ACETABULAR CUP LOOSENING. THE SURGEON NOTED INSUFFICIENT BONE INGROWTH AND THAT THE ACETABULAR CUP HAD SPUN. THE SURGEON ALSO NOTED A GRAYISH, MILKY MATERIAL BEHIND THE ACETABULAR CUP DURING THE REVISION PROCEDURE. CULTURES WERE TAKEN AND WERE NEGATIVE FOR INFECTION. THE ACETABULAR CUP WAS REMOVED AND REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	M2A MAGNUM PF CUP 52MM OD X 46MM ID	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	124570

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Hospitalization\| R