CORAIL2 LAT COXA VARA SIZE 13

Report

Report Number: 1818910-2014-17437
Event Type: Injury
Date Received: April 24, 2014
Date of Event: April 1, 2014
Report Date: April 1, 2014
Manufacturer: DEPUY FRANCE SAS
Product Code: KWA
PMA / PMN Number: PK042992
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

PATIENT WAS REVISED TO ADDRESS PAIN DUE TO STEM LOOSENING. THE STEM WAS ALSO FOUND TO BE IN VARUS AND UNDERSIZED. (B)(6). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. 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. 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 TO ADDRESS PAIN DUE TO STEM LOOSENING. THE STEM WAS ALSO FOUND TO BE IN VARUS AND UNDERSIZED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
249088	CORAIL2 LAT COXA VARA SIZE 13	HIP FEMORAL SLEEVE	KWA	DEPUY FRANCE SAS		5003615

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR		Required Intervention