M2A 1 PC SHELL 38MMX54MM

Report

Report Number: 0001825034-2013-03255
Event Type: Injury
Date Received: August 16, 2013
Date of Event: July 18, 2013
Report Date: June 30, 2016
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PK011110
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, 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: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." AND "LOOSENING OR MIGRATION OF IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY. " AND "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES. " THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 15-105056, NUMBER - 232030, EXPIRATION DATE - DECEMBER 31, 2015, MANUFACTURE DATE ¿ DECEMBER 14, 2005 OR THE PART/LOT INFORMATION COULD BE:- CATALOG NUMBER -15-105054, LOT NUMBER - 628630, EXPIRATION DATE - JANUARY 31, 2016, MANUFACTURE DATE ¿ JANUARY 16, 2006 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 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-03255 & 2014-03536/ -03537/ -03538).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4). PRODUCT LOCATION UNKNOWN.

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

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. 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.

Additional Manufacturer Narrative · 1

THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT ENROLLED IN A MOM CLINICAL STUDY UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PAIN. THE MODULAR HEAD AND ACETABULAR COMPONENT WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. LEGAL COUNSEL FURTHER REPORTS A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, NOISES, LOCKING SENSATION, LOOSENING OF THE RIGHT PROSTHESIS, METAL DEBRIS, FLUID, ELEVATED METAL ION LEVELS, METAL WEAR, METAL POISONING, BONE DEATH, TISSUE DEATH, LESIONS, AND LIMITATION OF DAILY ACTIVITIES. LEGAL COUNSEL FURTHER ALLEGES REACTIVE TISSUE, FOREIGN BODY SYNOVITIS, ABNORMAL REACTION TO METAL DEBRIS, BONE DEFICIENT ANTERIORLY AND SUPERIORLY, FIBRINOID NECROSIS, AND CYSTIC LESIONS WERE NOTED DURING REVISION PROCEDURE. NO LEFT HIP REVISION HAS BEEN REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT ENROLLED IN A MOM CLINICAL STUDY UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PAIN. THE MODULAR HEAD AND ACETABULAR COMPONENT WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. LEGAL COUNSEL FURTHER REPORTS A RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, NOISES, LOCKING SENSATION, LOOSENING OF THE RIGHT PROSTHESIS, METAL DEBRIS, FLUID, ELEVATED METAL ION LEVELS, METAL WEAR, METAL POISONING, BONE DEATH, TISSUE DEATH, LESIONS, AND LIMITATION OF DAILY ACTIVITIES. LEGAL COUNSEL FURTHER ALLEGES REACTIVE TISSUE, FOREIGN BODY SYNOVITIS, ABNORMAL REACTION TO METAL DEBRIS, BONE DEFICIENT ANTERIORLY AND SUPERIORLY, FIBRINOID NECROSIS, AND CYSTIC LESIONS WERE NOTED DURING REVISION PROCEDURE. NO LEFT HIP REVISION HAS BEEN REPORTED. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE RIGHT HIP REVISION PERFORMED ON (B)(6) 2013 WAS DUE TO PAIN AND ELEVATED METAL ION LEVELS. THE PATIENT'S OPERATIVE REPORT NOTED REACTIVE TISSUE CONSISTENT WITH SYNOVITIS/REACTION TO METAL DEBRIS, AND CYSTIC LESIONS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2012 AND (B)(6) 2014 PATIENT'S BLOOD WAS TESTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT ENROLLED IN A (B)(4), UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PAIN. THE MODULAR HEAD AND ACETABULAR COMPONENT WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
398643	M2A 1 PC SHELL 38MMX54MM	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	628630

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Hospitalization\| R