FDA Adverse Event Injury Summary report: N

UNKNOWN DEPUY METAL HEAD

MDR report key: 2924090 · Received January 22, 2013

Report

Report Number: 1818910-2013-11253
Event Type: Injury
Date Received: January 22, 2013
Date of Event: August 26, 2011
Report Date: January 14, 2013
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: KWY
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Additional Manufacturer Narrative · 1

THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

Additional Manufacturer Narrative · 1

CORRECTED: HEALTH PROFESSIONAL, OCCUPATION, REPORT SOURCE. THE INVESTIGATION IS STILL ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Description of Event or Problem · 1

MAUDE REPORT (B)(6) SUBMITTED BY AN ATTORNEY STATES THAT A PATIENT WAS REVISED BILATERALLY TO ADDRESS PAIN AND ELEVATED METAL LEVELS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
29640	UNKNOWN DEPUY METAL HEAD	FEMORAL HEAD	KWY	DEPUY ORTHOPAEDICS, INC.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention