M2A-MAGNUM MOD HD SZ 42MM

Report

Report Number: 0001825034-2013-00487
Event Type: Injury
Date Received: March 7, 2013
Date of Event: February 9, 2010
Report Date: February 20, 2015
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PK042037
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN, PMA/510(K) NUMBER - UNKNOWN, MANUFACTURE DATE - UNKNOWN. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PERSON(REFERENCE 1825034-2013-00486 / 00487).

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PART AND LOT 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 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." 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 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00486 / 00487).

Additional Manufacturer Narrative · 1

THIS 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 THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS. A LOW INCIDENCE OF METAL HYPERSENSITIVITY HAS BEEN REPORTED WITH FAILED METAL-ON-METAL IMPLANTS." NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR, PARTICULARLY IN THE PRESENCE OF POOR BONE STOCK CAUSED BY OSTEOPOROSIS, BONE DEFECTS FROM PREVIOUS SURGERY, BONE RESORPTION, OR WHILE INSERTING THE DEVICE." THIS REPORT IS NUMBER 2 OF 3 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-00486, 2013-00487 & 2015-00953).

Description of Event or Problem · 1

PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2012 AND A LEFT HIP REVISION ON (B)(6) 2010. DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION AND LOSS OF RANGE OF MOTION. 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 RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2012 AND A LEFT HIP REVISION ON (B)(6) 2010. DUE TO PATIENT ALLEGATIONS OF PAIN, DAMAGE TO SURROUNDING BONE AND TISSUE, INFLAMMATION, DISCOMFORT, SORENESS, DYSFUNCTION AND LOSS OF RANGE OF MOTION. 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 RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2012 AND A LEFT HIP REVISION ON (B)(6) 2010. DUE TO PATIENT ALLEGATIONS OF PAIN, DAMAGE TO SURROUNDING BONE AND TISSUE, INFLAMMATION, DISCOMFORT, SORENESS, DYSFUNCTION AND LOSS OF RANGE OF MOTION. 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. ADDITIONAL INFORMATION RECEIVED IN AN OPERATIVE REPORT DATED (B)(6) 2010 NOTES THE LEFT HIP REVISION OCCURRED DUE TO PAIN, LOOSENING OF THE ACETABULAR CUP AND POSSIBLE METAL HYPERSENSITIVITY. THE OPERATIVE REPORT NOTES INGROWTH FAILURE, LOOSENING AND MICROMOTION OF THE ACETABULAR CUP. OPERATIVE REPORT FURTHER NOTES MODERATE SCLEROSIS AROUND THE ACETABULAR CUP. DURING THE PROCEDURE, THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED AND A POLYETHYLENE LINER WAS IMPLANTED. AN OPERATIVE REPORT DATED (B)(6) 2012 NOTES THE RIGHT HIP REVISION OCCURRED DUE TO PAIN AND POSSIBLE METAL HYPERSENSITIVITY. THE OPERATIVE REPORT NOTES BROWN STAINING OF THE PSEUDOCAPSULE, THE PRESENCE OF THICK, YELLOW, OILY FLUID WITHIN THE JOINT AND MILD CHANGES IN THE PERIARTICULAR AREA. DURING THE PROCEDURE, THE MODULAR HEAD WAS REMOVED AND REPLACED AND AN ACTIVE ARTICULATION LINER WAS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
96660	M2A-MAGNUM MOD HD SZ 42MM	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	608060

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR		Hospitalization\| R