FDA Adverse Event Injury Summary report: N

ATTUNE FB TIB BASE SZ 4 CEM

MDR report key: 3972147 · Received July 31, 2014

Report

Report Number: 1818910-2014-24513
Event Type: Injury
Date Received: July 31, 2014
Date of Event: July 15, 2014
Report Date: July 16, 2014
Manufacturer: DEPUY ORTHOPAEDICS, INC. 1818910
Product Code: JWH
PMA / PMN Number: PK101433
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: 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

CONCLUSION AND JUSTIFICATION STATUS FOR MDR: THE DEVICE ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. THE INITIAL REPORTING STATED NO ADDITIONAL INVESTIGATIONAL INPUTS WERE AVAILABLE. 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

PROCEDURE: ATTUNE TOTAL KNEE REVISION. KNEE WAS REVISED DUE TO INFECTION. SOURCE OF INFECTION IS UNKNOWN. SURGEON DID NOT MAKE ANY COMMENTS TO INDICATE THAT INFECTION WAS DUE TO FAULT OR FAILURE OF PROSTHESIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
448004	ATTUNE FB TIB BASE SZ 4 CEM	KNEE TIBIAL TRAY	JWH	DEPUY ORTHOPAEDICS, INC. 1818910		4107235

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Required Intervention