FDA Adverse Event Injury Summary report: N

DLT TS CER HD 12/14 40MM +1.5

MDR report key: 2831467 · Received November 14, 2012

Report

Report Number: 1818910-2012-26798
Event Type: Injury
Date Received: November 14, 2012
Date of Event: October 16, 2012
Report Date: October 16, 2012
Manufacturer: DEPUY IRELAND
Product Code: LZO
PMA / PMN Number: K071830
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE DLT TS CER HD AS THE LOT CODE REQUIRED WAS 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 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. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Description of Event or Problem · 1

PATIENT WAS REVISED TO ADDRESS INFECTION. (LEFT HIP).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DLT TS CER HD 12/14 40MM +1.5	FEMORAL HEAD	LZO	DEPUY IRELAND		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Required Intervention