ASR UNI FEMORAL IMPL SIZE 46

MDR report key: 2802117 · Received October 23, 2012

Report

Report Number: 1818910-2012-23764
Event Type: Injury
Date Received: October 23, 2012
Date of Event: June 12, 2012
Report Date: August 20, 2013
Manufacturer: DEPUY INTERNATIONAL
Product Code: KWA
PMA / PMN Number: PK040627
Removal / Correction Number: Z-1749/1816-2011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

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 ALLEGED THE ASR HIP WAS EXPLANTED AND REPLACED DUE TO A FAILURE WHICH SUBSEQUENTLY LED TO HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS WITHIN THE PATIENTS BLOOD.

Description of Event or Problem · 1

UPDATE (B)(4) 2013 - CLINICAL REPORT WAS RECEIVED. REPORT INDICATES THE PATIENT HAS HAD TROCHANTERIC BURSITIS AND RADICULOPATHY SINCE THE REVISION ON (B)(6) 2012. THE PATIENT HAS NOT BEEN REVISED A SECOND TIME. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. UPDATING PART/LOT INFORMATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ASR UNI FEMORAL IMPL SIZE 46	FEMORAL HEAD HIP IMPLANT	KWA	DEPUY INTERNATIONAL		3011764

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR		Other