FDA Adverse Event Injury Summary report: N

M2A-MAGNUM PF CUP 56ODX50ID

MDR report key: 2761001 · Received September 26, 2012

Report

Report Number: 0001825034-2012-01709
Event Type: Injury
Date Received: September 26, 2012
Report Date: August 28, 2012
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PK042037
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

EVENT DATE & EXPLANT DATE - NO KNOWN REVISION PROCEDURE HAS OCCURRED. 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, NUMBER ONE STATES, "MATERIAL SENSITIVITY REACTIONS". ON MORE RECENT VERSIONS OF THE PACKAGE INSERT, NUMBER FIFTEEN STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01709 AND 1825034-2012-01740 / 01741).

Description of Event or Problem · 1

LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, COUNSEL ALLEGES ELEVATED METAL ION LEVELS AND TISSUE AND BONE DESTRUCTION. NO KNOWN REVISION PROCEDURE HAS OCCURRED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	M2A-MAGNUM PF CUP 56ODX50ID	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	588320

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R