FDA Adverse Event Injury Summary report: N

UNKNOWN M2A HEAD

MDR report key: 3875006 · Received June 16, 2014

Report

Report Number: 0001825034-2014-05524
Event Type: Injury
Date Received: June 16, 2014
Report Date: May 23, 2014
Manufacturer: BIOMET ORTHOPEDICS
Product Code: KWA
PMA / PMN Number: PUNKNOWN
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: ATTORNEY

Narratives

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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

Description of Event or Problem · 1

LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT AND DIFFICULTY WALKING. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. 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
353059	UNKNOWN M2A HEAD	PROSTHESIS, HIP	KWA	BIOMET ORTHOPEDICS	N/A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention