FDA Adverse Event Injury Summary report: N

DEPUY ASR XL FEM IMP SIZE 46

MDR report key: 3850048 · Received June 4, 2014

Report

Report Number: 1818910-2014-20224
Event Type: Injury
Date Received: June 4, 2014
Date of Event: April 15, 2014
Report Date: May 19, 2014
Manufacturer: DEPUY INTERNATIONAL LTD. 8010379
Product Code: KXA
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: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.

Description of Event or Problem · 1

ASR REVISION TO TAKE PLACE ON (B)(6) 2014.ASR XL.RIGHT.REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.UPDATE - RECEIVED CONFIRMATION THAT REVISION HAS TAKEN PLACE. TAKEN FROM (B)(6) SPREADSHEET DATED (B)(6) 2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
326702	DEPUY ASR XL FEM IMP SIZE 46	HIP FEMORAL HEAD	KXA	DEPUY INTERNATIONAL LTD. 8010379		2699908

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention