FDA Adverse Event Injury Summary report: N

CORAIL2 STD SIZE 14

MDR report key: 4260194 · Received November 18, 2014

Report

Report Number: 1818910-2014-31897
Event Type: Injury
Date Received: November 18, 2014
Date of Event: April 10, 2012
Report Date: November 4, 2014
Manufacturer: DEPUY FRANCE SAS
Product Code: KWA
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PATIENT

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.

Description of Event or Problem · 1

NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT (B)(4) REASON FOR ORIGINAL COMPLAINT ¿ASR REVISION.ASR XL ACETABULAR SYSTEM (LEFT).REASON(S) FOR REVISION: PAIN. UPDATE - ADDED SURGEON TAKEN FROM CLAIMSUITE DATED (B)(6) 2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
746754	CORAIL2 STD SIZE 14	HIP FEMORAL STEM/SLEEVE	KWA	DEPUY FRANCE SAS		2818542

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention