FDA Adverse Event Injury Summary report: N

ASR UNI FEMORAL IMPL SIZE 53

MDR report key: 2872668 · Received December 13, 2012

Report

Report Number: 1818910-2012-22353
Event Type: Injury
Date Received: December 13, 2012
Date of Event: November 30, 2012
Report Date: November 30, 2012
Manufacturer: DEPUY INTERNATIONAL
Product Code: KWA
PMA / PMN Number: K040627
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, 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.

Description of Event or Problem · 1

LITIGATION PAPERS ALLEGE ON VARIOUS DATES BEGINNING SHORTLY AFTER SURGERY, PATIENT SUFFERED PERMANENT PHYSICAL INJURIES, SIGNIFICANT PAIN, SORENESS AND DISCOMFORT; DIFFICULTY SLEEPING, WALKING, AND PERFORMING ROUTINE ACTIVITIES; INABILITY TO LEAD A NORMAL LIFE; ELEVATED METAL ION LEVELS; EMOTIONAL DISTRESS, ANXIETY, AND MENTAL ANGUISH; ECONOMIC LOSSES INCLUDING PAST AND FUTURE MEDICAL EXPENSES, LOSS OF EARNINGS, AND IMPAIRED EARNING CAPACITY. UPDATE: (B)(6) 2012-SALES REP REPORTED REVISION SURGERY DUE TO PAIN, CUP LOOSENING. NO METALLOSIS WAS NOTED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ASR UNI FEMORAL IMPL SIZE 53	FEMORAL HEAD	KWA	DEPUY INTERNATIONAL		2519323

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention