FDA Adverse Event Injury Summary report: N

UNKNOWN DEPUY 12.5MM PS TIB INSERT

MDR report key: 3014225 · Received March 21, 2013

Report

Report Number: 1818910-2013-14167
Event Type: Injury
Date Received: March 21, 2013
Date of Event: March 12, 2013
Report Date: March 12, 2013
Manufacturer: 1818910 DEPUY ORTHOPAEDICS, INC.
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEW AND/OR SEARCHING THE COMPLAINT DATABASE WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION 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 SUBSIDENCE AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT/IMPLANT INTERFACE. THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN. OSTEOLYSIS WAS ALSO REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
118655	UNKNOWN DEPUY 12.5MM PS TIB INSERT	TIBIAL KNEE INSERT	JWH	1818910 DEPUY ORTHOPAEDICS, INC.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Required Intervention