FDA Adverse Event Death Summary report: N

TOTAL ASR ACET IMP SIZE 58

MDR report key: 4812313 · Received June 2, 2015

Report

Report Number: 1818910-2015-22492
Event Type: Death
Date Received: June 2, 2015
Date of Event: May 25, 2015
Manufacturer: DEPUY INTERNATIONAL LTD. 8010379
Product Code: KWA
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FI
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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. (B)(4).

Description of Event or Problem · 1

WE HAVE BEEN INFORMED BY (B)(6) THAT THIS PATIENT IS DECEASED. THE DATE OF DEATH IS (B)(6) 2014 - THE EXACT DATE IS NOT KNOWN. RIGHT; XL; HIGH METAL IONS IN BLOOD WERE PRESENT. OTHER CONDITION: HEART FAILURE, ARRHYTHMIA, CORONARY ARTERY DISEASE. POLYCYTHEMIA VERA. PATIENT DID NOT UNDERGO REVISION SURGERY

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
356670	TOTAL ASR ACET IMP SIZE 58	HIP ACETABULAR CUP	KWA	DEPUY INTERNATIONAL LTD. 8010379		2771818

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR		Death