FDA Adverse Event Injury Summary report: N

ASR ACETABULAR CUPS 56

MDR report key: 2141281 · Received June 22, 2011

Report

Report Number: 1818910-2011-10868
Event Type: Injury
Date Received: June 22, 2011
Date of Event: March 1, 2011
Report Date: May 23, 2011
Manufacturer: DEPUY INTERNATIONAL, LTD.
Product Code: KWA
PMA / PMN Number: K040627
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: ATTORNEY

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.

Additional Manufacturer Narrative · 1

(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Description of Event or Problem · 1

LITIGATION PAPERS ALLEGE: ON (B)(6) 2009, PT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS RIGHT SIDE. PT HAS SINCE THEN SUFFERED ECONOMIC LOSSES INCLUDING, BUT NOT LIMITED TO, LOSS OF HIS JOB, LOSS OF INCOME AND FRINGE BENEFITS, AND MEDICAL, PHARMACEUTICAL AND OTHER INCIDENTAL EXPENSES. THERE IS NO MENTION OF A REVISION SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ASR ACETABULAR CUPS 56	ACETABULAR CUP HIP IMPLANT	KWA	DEPUY INTERNATIONAL, LTD.	NA	2780742

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA		Required Intervention