FDA Adverse Event Injury Summary report: N

UNKNOWN DEPUY CORAIL STEM

MDR report key: 2900766 · Received January 8, 2013

Report

Report Number: 1818910-2013-10560
Event Type: Injury
Date Received: January 8, 2013
Date of Event: December 27, 2012
Report Date: December 27, 2012
Manufacturer: DEPUY FRANCE S.A.S.-SAINT PRIEST
Product Code: JDI
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

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.

Additional Manufacturer Narrative · 1

PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, POLY WEAR, AND STEM LOOSENING. DOI UNK - DOR (B)(6) 2012 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

Description of Event or Problem · 1

PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, POLY WEAR, AND STEM LOOSENING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
9796	UNKNOWN DEPUY CORAIL STEM	FEMORAL HIP STEM	JDI	DEPUY FRANCE S.A.S.-SAINT PRIEST		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Required Intervention