SIGMA XLK CVD PLUS INS 2 15MM

Report

Report Number: 1818910-2014-22719
Event Type: Injury
Date Received: July 5, 2014
Date of Event: June 20, 2014
Report Date: June 20, 2014
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: JWH
PMA / PMN Number: PK040166
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

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 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 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.

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.

Description of Event or Problem · 1

RECEIVED MAIL THAT PATIENT FRACTURED LATERAL TUBEROSITY OF TIBIA LEADING TO INSTABILITY OF KNEE JOINT. THE SURGEON DID LEFT TKR ON (B)(6) 2012, USING JNJ CR 150 DEPUY WITH 15 MM INSERT, BUT TILL DATE SHE CAN'T WALK PROPERLY. INSTABILITY IS STILL THERE. PATIENT EXPERIENCES INSTABILITY IN LEFT KNEE POST TKR. EXACT DATE OF EVENT IS NOT KNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
392941	SIGMA XLK CVD PLUS INS 2 15MM	KNEE TIBIAL BEARING/INSERT	JWH	DEPUY ORTHOPAEDICS, INC.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR