PFC* CEMENTED FEM STEM, SZ 4M

Report

Report Number: 1818910-2014-23706
Event Type: Injury
Date Received: July 18, 2014
Date of Event: December 1, 2005
Report Date: June 19, 2014
Manufacturer: 1818910 DEPUY ORTHOPAEDICS, INC.
Product Code: JDI
PMA / PMN Number: PK953202
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CO, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT AND LOT COMBINATION FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

Description of Event or Problem · 1

CLINICAL REPORT STATES THAT THE PATIENT WAS REVISED BECAUSE OF MIGRATION/LOOSENING OF THE STEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
421777	PFC* CEMENTED FEM STEM, SZ 4M	HIP FEMORAL STEM/SLEEVE	JDI	1818910 DEPUY ORTHOPAEDICS, INC.		590385

Patients

Seq	Age	Sex	Outcome	Treatment
1	86 YR		Required Intervention