FDA Adverse Event Injury Summary report: N

TOTAL ASR ACET IMP SIZE 56

MDR report key: 4851356 · Received June 17, 2015

Report

Report Number: 1818910-2015-23835
Event Type: Injury
Date Received: June 17, 2015
Date of Event: May 6, 2015
Report Date: June 17, 2015
Manufacturer: DEPUY INTL., LTD. - 8010379
Product Code: KWA
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
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. REF. (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. UDI: (B)(4).

Description of Event or Problem · 1

ASR REVISION, LEFT, ASR XL, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
395241	TOTAL ASR ACET IMP SIZE 56	HIP ACETABULAR CUP	KWA	DEPUY INTL., LTD. - 8010379		2417420

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention