FDA Adverse Event Injury Summary report: N

ASR ACETABULAR IMPLANT 64

MDR report key: 3903963 · Received July 1, 2014

Report

Report Number: 1818910-2014-22364
Event Type: Injury
Date Received: July 1, 2014
Date of Event: June 17, 2014
Report Date: June 26, 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: FI
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. 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.

Description of Event or Problem · 1

ASR REVISION; ASR RESURFACING- RIGHT; REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
383141	ASR ACETABULAR IMPLANT 64	HIP ACETABULAR CUP	KWA	DEPUY INTERNATIONAL LTD. 8010379		2158482

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention