MCLAUGHLIN +5 ACETABULAR SHELL 60MMX23L

Report

Report Number: 0001825034-2013-01181
Event Type: Injury
Date Received: April 26, 2013
Date of Event: October 20, 2011
Report Date: December 2, 2013
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PK050124
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NV, 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 ¿LOOSENING OR MIGRATION OF IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY.¿ AND ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿

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: "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01176 / 01181).

Description of Event or Problem · 1

LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DIFFICULTY WALKING, STIFFNESS AND GRINDING. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, DIFFICULTY WALKING, STIFFNESS AND GRINDING OF THE RIGHT HIP; HOWEVER, A REVISION PROCEDURE FOR THE RIGHT HIP HAS NOT BEEN REPORTED. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH PRIMARY SURGERY DATES AND THAT THE ACETABULAR CUP, LINER AND HEAD WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE ON (B)(6) 2011. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT¿S REVISION OPERATIVE REPORT FOR THE LEFT HIP NOTES THE PRESENCE OF PAIN, SYNOVIAL METALLOSIS, A CYST AND THE ACETABULAR CUP LOOSENING. THE MODULAR HEAD, ACETABULAR CUP AND TAPER LINER WERE REMOVED AND REPLACED. PATIENT'S MEDICAL RECORDS INDICATE THAT THE LEFT HIP COMPONENTS WERE IMPLANTED (B)(6) 2004 AND THE RIGHT HIP ARTHROPLASTY WAS PERFORMED (B)(6) 2004.

Description of Event or Problem · 1

LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, DIFFICULTY WALKING, STIFFNESS AND GRINDING. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, DIFFICULTY WALKING, STIFFNESS AND GRINDING OF THE RIGHT HIP; HOWEVER, A REVISION PROCEDURE FOR THE RIGHT HIP HAS NOT BEEN REPORTED. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH PRIMARY SURGERY DATES AND THAT THE ACETABULAR CUP, LINER AND HEAD WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE ON (B)(6) 2011. 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
181027	MCLAUGHLIN +5 ACETABULAR SHELL 60MMX23L	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	119980

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Hospitalization\| R