M2A-MAGNUM MOD HD SZ 46MM

Report

Report Number: 0001825034-2013-00398
Event Type: Injury
Date Received: February 27, 2013
Date of Event: January 2, 2013
Report Date: July 14, 2014
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PK042037
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, 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, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00396 / 00398).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

Additional Manufacturer Narrative · 1

THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 ALLEGEDLY DUE TO METALLOSIS AND PAIN. THE HEAD, CUP AND TAPER INSERT WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT AND A BIOMET HEAD.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT AN INITIAL TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 ALLEGEDLY DUE TO METALLOSIS AND PAIN. THE HEAD, CUP AND TAPER INSERT WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT AND A BIOMET HEAD. ADDITIONAL INFORMATION RECEIVED FROM PATIENT¿S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY AND RANGE OF MOTION, SORENESS, DYSFUNCTION, AND ELEVATED METAL ION LEVELS, METAL POISONING, AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT UNDERWENT AN INITIAL TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 ALLEGEDLY DUE TO METALLOSIS AND PAIN. THE HEAD, CUP AND TAPER INSERT WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT AND A BIOMET HEAD. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY AND RANGE OF MOTION, SORENESS, DYSFUNCTION, AND ELEVATED METAL ION LEVELS, METAL POISONING, AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013 DUE TO PAIN AND A MALPOSITIONED ACETABULAR CUP. OPERATIVE REPORT NOTED THE PRESENCE OF METALLOSIS, BLACK METALLIC TISSUE, FIBROUS TISSUE, ANTERIOR WALL DEFECT, AND DARK METALLIC FRAGMENTS IN THE ACETABULUM BONE. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH COMPETITOR'S ACETABULAR COMPONENTS AND A BIOMET HEAD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
84249	M2A-MAGNUM MOD HD SZ 46MM	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	789290

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Hospitalization\| R