M2A-MAGNUM MOD HD SZ 46MM

Report

Report Number: 0001825034-2013-01892
Event Type: Injury
Date Received: June 11, 2013
Date of Event: August 10, 2011
Report Date: May 14, 2013
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PK042037
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, 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 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 BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 8 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01889 / 01896).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY REVISION DATES AND THE REASON FOR THE REVISION RECEIVED IN MEDICAL RECORDS, WHICH 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, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS NUMBER 4 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01889 / 01894).

Description of Event or Problem · 1

PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS, TISSUE/BONE DESTRUCTION, PAIN, SWELLING, INFLAMMATION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, AND LOSS OF RANGE OF MOTION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. 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.

Description of Event or Problem · 1

PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS, TISSUE/BONE DESTRUCTION, PAIN, SWELLING, INFLAMMATION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, AND LOSS OF RANGE OF MOTION. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT A LEFT HIP REVISION PROCEDURE TOOK PLACE ON (B)(6) 2010 DUE TO CASEOUS FLUID, PAIN AND A METAL ON METAL REACTION. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, TAPER ADAPTER AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS FURTHER INDICATES THAT A RIGHT HIP REVISION PROCEDURE TOOK PLACE ON (B)(6) 2011 DUE TO A FLUID COLLECTION WITH A CASEOUS APPEARANCE. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, TAPER ADAPTER AND MODULAR HEAD WERE REMOVED AND REPLACED. 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
262397	M2A-MAGNUM MOD HD SZ 46MM	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	467670

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR		Hospitalization\| R