FDA Adverse Event Injury Summary report: N

PFC SIGMA STAB INS SZ3 8MM

MDR report key: 2925209 · Received January 22, 2013

Report

Report Number: 1818910-2013-11308
Event Type: Injury
Date Received: January 22, 2013
Date of Event: January 8, 2013
Report Date: January 8, 2013
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: JWH
PMA / PMN Number: PK950010
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, 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. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) 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.

Description of Event or Problem · 1

PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND POLY WEAR OF THE TIBIAL INSERT. LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/BONE INTERFACE WAS ALSO REPORTED; HOWEVER, 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
30943	PFC SIGMA STAB INS SZ3 8MM	TIBIAL KNEE INSERT	JWH	DEPUY ORTHOPAEDICS, INC.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention