FDA Adverse Event Injury Summary report: N

M2A-MAGNUM 42-50M TPR INSRT +3

MDR report key: 2829579 · Received November 13, 2012

Report

Report Number: 0001825034-2012-02401
Event Type: Injury
Date Received: November 13, 2012
Date of Event: November 18, 2008
Report Date: October 17, 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: CA, US
Reporter Occupation: ATTORNEY

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 1 STATES: "MATERIAL SENSITIVITY REACTIONS."AND NUMBER 14 "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-002398 / 02402).

Description of Event or Problem · 1

LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2003. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED (B)(6) 2004 AND ANOTHER REVISION ON (B)(6) 2008 DUE TO PAIN, ELEVATED METAL ION LEVELS, INFLAMMATION AND COMPLICATIONS WITH WALKING AND STAIRS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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 42-50M TPR INSRT +3	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	496010

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Hospitalization\| R