FDA Adverse Event Injury Summary report: N

MBT CEM KEEL TIB TRAY SZ3

MDR report key: 2901983 · Received January 8, 2013

Report

Report Number: 1818910-2013-10591
Event Type: Injury
Date Received: January 8, 2013
Date of Event: January 2, 2013
Report Date: January 2, 2013
Manufacturer: DEPUY IRELAND ¿ REG. # 9616671
Product Code: NJL
PMA / PMN Number: PP830055
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, 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

THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. 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 DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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

PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE, AND IT HAD ALSO SUBSIDED/COLLAPSED INTO VARUS. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
9979	MBT CEM KEEL TIB TRAY SZ3	TIBIAL KNEE PROSTHESIS	NJL	DEPUY IRELAND ¿ REG. # 9616671		62990497

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Required Intervention