FDA Adverse Event Injury Summary report: N

UNKNOWN DEPUY STD PATELLA

MDR report key: 3934895 · Received July 15, 2014

Report

Report Number: 1818910-2014-23376
Event Type: Injury
Date Received: July 15, 2014
Date of Event: June 20, 2014
Report Date: June 20, 2014
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, 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

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 AND LOT CODE REQUIRED WAS NOT PROVIDED. 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 INDICATEDDEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

PATIENT WAS REVISED BECAUSE THE POLY PORTION OF THE PATELLA BECAME DISASSOCIATED FROM THE METAL PORTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
414019	UNKNOWN DEPUY STD PATELLA	KNEE PATELLAR COMPONENT	JWH	DEPUY ORTHOPAEDICS, INC.		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Required Intervention