M2A-MAGNUM MOD HD SZ 42MM

Report

Report Number: 0001825034-2014-04405
Event Type: Injury
Date Received: May 20, 2014
Date of Event: March 11, 2013
Report Date: September 3, 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: NM, US
Reporter Occupation: ATTORNEY

Narratives

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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "FRETTING AND CREVICE CORROSION MAY OCCUR AT INTERFACES BETWEEN COMPONENTS." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 5 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04404 /-04405 /-04406 /-04407 /-07638).

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 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ 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 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04404 / 04407).

Description of Event or Problem · 1

PATIENT'S LEGAL COUNSEL REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING AND METALLOSIS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE RIGHT HIP TO DATE. REVIEW OF INVOICE HISTORY INDICATES PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 WHEREIN HIP SPACER MOLDS WERE IMPLANTED. 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

PATIENT'S LEGAL COUNSEL REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING AND METALLOSIS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE RIGHT HIP TO DATE. REVIEW OF INVOICE HISTORY INDICATES PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013 WHEREIN HIP SPACER MOLDS WERE IMPLANTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2013 DUE TO PAIN AND INABILITY TO BEAR WEIGHT. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF SWELLING, SCAR TISSUE, BONE LOSS, HEAD/TAPER ADAPTER COLD WELDED ONTO STEM, DEVITALIZED TISSUE, AND A FRACTURE OF THE GREATER TROCHANTER. ALL COMPONENTS WERE REMOVED AND REPLACED WITH SPACER MOLDS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
300455	M2A-MAGNUM MOD HD SZ 42MM	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	765020

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Hospitalization\| R