FDA Adverse Event Injury Summary report: N

ASR UNI FEMORAL IMPL SIZE 51

MDR report key: 2864161 · Received December 10, 2012

Report

Report Number: 1818910-2012-28377
Event Type: Injury
Date Received: December 10, 2012
Report Date: December 14, 2011
Manufacturer: DEPUY INTERNATIONAL
Product Code: KWA
PMA / PMN Number: K040627
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. NOT RETURNED.

Description of Event or Problem · 1

LITIGATION PAPERS ALLEGE: PATIENT WILL NEED TO UNDERGO A REVISION SURGERY, ALSO HE IS AT RISK OF TOXIC LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE: (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED (PART/LOT) INFORMATION AND DATE OF REVISION FOR THE RIGHT HIP. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(4) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND DATE OF REVISION FOR THE LEFT SIDE. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ASR UNI FEMORAL IMPL SIZE 51	FEMORAL HEAD	KWA	DEPUY INTERNATIONAL		2727788

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other