FDA Adverse Event Injury Summary report: N

CORAIL2 NON COL HO SIZE 12

MDR report key: 4070671 · Received September 9, 2014

Report

Report Number: 1818910-2014-27497
Event Type: Injury
Date Received: September 9, 2014
Date of Event: October 26, 2012
Report Date: February 2, 2015
Manufacturer: DEPUY FRANCE SAS
Product Code: KWA
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

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

ASR REVISION; RIGHT; RESURFACING; REASON FOR REVISION: UNKNOWN. UPDATE 27 AUG 2014 - SCF ATTACHED. ADDING PAIN AND NOISE AS REASONS FOR REVISION. XL NOT RESURFACING AS PREVIOUSLY REPORTED. ADDED SURGEON. SLEEVE AND STEM ADDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
553461	CORAIL2 NON COL HO SIZE 12	HIP FEMORAL STEM/SLEEVE	KWA	DEPUY FRANCE SAS		1884964

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR	Unknown	Required Intervention