UNKNOWN DEPUY ATTUNE TIBIA COMPONENT

Report

Report Number: 1818910-2015-26539
Event Type: Injury
Date Received: July 27, 2015
Date of Event: January 30, 2015
Report Date: July 9, 2015
Manufacturer: DEPUY ORTHOPAEDICS, INC.
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER

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. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE. 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

NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. (B)(4) HAS BEEN UNDERTAKEN TO INVESTIGATE FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE 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 DUE TO PAIN AND LOOSENING. DEPUY CEMENT WAS USED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
486411	UNKNOWN DEPUY ATTUNE TIBIA COMPONENT	KNEE TIBIAL BEARING/INSERT	JWH	DEPUY ORTHOPAEDICS, INC.		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR		Required Intervention