M2A 38MM MOD HD -3MM NK

Report

Report Number: 0001825034-2013-01771
Event Type: Injury
Date Received: May 31, 2013
Date of Event: June 23, 2012
Report Date: October 18, 2013
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PK011110
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, 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. 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 2 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01770 / 01775).

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. THIS REPORT IS NUMBER 2 OF 7 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-01770 THRU -01775 / -05063).

Description of Event or Problem · 1

LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING AND METALLOSIS. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS THE LEFT INITIAL HIP ARTHROPLASTY OCCURRED ON (B)(6) 2004 AND THE RIGHT INITIAL HIP ARTHROPLASTY OCCURRED ON (B)(6) 2007. SUBSEQUENTLY, PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2012 DUE TO UNKNOWN REASONS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE ON THE RIGHT HIP. 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

LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING AND METALLOSIS. ADDITIONAL INFORMATION PROVIDED IN A REVIEW OF INVOICE HISTORY CONFIRMS THE LEFT INITIAL HIP ARTHROPLASTY OCCURRED ON (B)(6) 2004 AND THE RIGHT INITIAL HIP ARTHROPLASTY OCCURRED ON (B)(6) 2007. SUBSEQUENTLY, PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2012 AND (B)(6) 2012 DUE TO UNKNOWN REASONS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE ON THE RIGHT HIP. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATE THAT THE LEFT TOTAL HIP ARTHROPLASTY TOOK PLACE ON (B)(6) 2004 AND PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2012 DUE TO INSTABILITY. REVISION OPERATIVE REPORT NOTED COTTAGE CHEESE-LIKE INFLAMMATORY MATERIAL AROUND THE JOINT AND METAL DEBRIS UNDER HEAD. THE HEAD AND CUP WERE REMOVED AND REPLACED. SUBSEQUENTLY, FURTHER LEFT HIP REVISION OCCURRED ON (B)(6) 2012 DUE TO A QUADRILATERAL ACETABULAR FRACTURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
241631	M2A 38MM MOD HD -3MM NK	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	015280

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Hospitalization\| R