LCS COMP RP INSERT STD 10MM

MDR report key: 2770184 · Received October 3, 2012

Report

Report Number: 1818910-2012-20237
Event Type: Injury
Date Received: October 3, 2012
Date of Event: September 27, 2012
Report Date: September 27, 2012
Manufacturer: DEPUY RAYNHAM
Product Code: NJL
PMA / PMN Number: P830055/S074
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

SERIOUS INJURY IS UNLIKELY. NO HARM TO PATIENT, NO SIGNIFICANT DELAY.

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. 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.

Description of Event or Problem · 1

PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS. LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT/BONE INTERFACE WAS ALSO REPORTED; HOWEVER, COMPETITOR CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION. (LEFT KNEE).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LCS COMP RP INSERT STD 10MM	TIBIAL KNEE INSERT	NJL	DEPUY RAYNHAM		YB6CK4000

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Required Intervention