FDA Adverse Event Injury Summary report: N

TOTAL ASR ACET IMP SIZE 50

MDR report key: 2861432 · Received December 7, 2012

Report

Report Number: 1818910-2012-25730
Event Type: Injury
Date Received: December 7, 2012
Date of Event: February 13, 2012
Report Date: October 14, 2014
Manufacturer: DEPUY INTERNATIONAL LTD. 8010379
Product Code: KWA
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: PATIENT

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.THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

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.DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

Description of Event or Problem · 1

ASR REVISION;RIGHT ASR XL;REASON FOR REVISION: PAIN.

Description of Event or Problem · 1

(B)(4). ASR REVISION. RIGHT. ASR XL. REASON(S) FOR REVISION: PAIN. (B)(4). UPDATE - RECREATED TO ADD THE NON DEPUY STEM SENTENCE. SEE BELOW. TAKEN FROM CLAIMSUITE DATED 14TH OCTOBER 2014 THIS COM IS TO BE CLOSED TO CAPA DUE TO THE REASONS FOR REVISION FALLING WITHIN THE CAPA REMIT AND OFF LABEL USE OF A COMPETITOR STEM

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TOTAL ASR ACET IMP SIZE 50	HIP ACETABULAR CUP	KWA	DEPUY INTERNATIONAL LTD. 8010379		2348536

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention