FDA Adverse Event Injury Summary report: N

PFC*SIGMA C/S NPOR FE LT SZ2.5

MDR report key: 2854320 · Received December 3, 2012

Report

Report Number: 1818910-2012-83021
Event Type: Injury
Date Received: December 3, 2012
Date of Event: November 19, 2012
Report Date: November 19, 2012
Manufacturer: DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
Product Code: JWH
PMA / PMN Number: PK950010
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PHYSICIAN

Narratives

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 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 LOOSENING OF THE FEMORAL COMPONENT AT BOTH INTERFACES, WHICH WAS CAUSING PAIN. THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PFC*SIGMA C/S NPOR FE LT SZ2.5	FEMORAL KNEE PROSTHESIS	JWH	DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS		299968

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Required Intervention