FDA Adverse Event Injury Summary report: N

S-ROM*SLEEVE PRX ZTT, 18D-LRG

MDR report key: 2920712 · Received January 17, 2013

Report

Report Number: 1818910-2013-00522
Event Type: Injury
Date Received: January 17, 2013
Date of Event: June 3, 2012
Report Date: December 21, 2012
Manufacturer: DEPUY IRELAND
Product Code: MRA
PMA / PMN Number: P070026
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS STILL UNDER INVESTIGATION.

Description of Event or Problem · 1

LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, THROBBING, MOBILITY ISSUES, AND METALLOSIS. UPDATE: (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED FROM LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE ON DISC IF NEEDED FOR FURTHER REVIEW. IT WAS ALSO NOTED IN THE REVISION OPERATIVE REPORT THAT THE STEMW AS LOOSE AND THE CUP WAS IN A VERTICAL POSITION, SO THEY WERE ADDED TO THE COMPLAINT. THE LINER REMOVED WAS REPORTED ON (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
25716	S-ROM*SLEEVE PRX ZTT, 18D-LRG	FEMORAL SLEEVE	MRA	DEPUY IRELAND		2860029

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Required Intervention