MAUDE Adverse Event Report: DEPUY IRELAND-9616671 DEPUY DUOFIX MBT TRAY SZ 5; KNEE TIBIAL TRAY

Catalog Number 900309000

Device Problem Metal Shedding Debris (1804)

Patient Problem Foreign Body Reaction (1868)

Event Date 12/09/2013

Event Type  Injury  

Event Description

Procedure: lcs duofix revision - left knee.Originally implanted on (b)(6) 2009.Revision surgery performed on (b)(6) 2013 by the same surgeon.Update (b)(6) 2013 reason for revision metalosis.

Manufacturer Narrative

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.

Manufacturer Narrative

The lcs duofix femoral components were voluntarily recalled from the market in july 2009, and the lcs duofix femoral product codes are now considered inactive.Further inspection of components will not be performed as the investigation regarding the root cause(s) and/or corrective actions are controlled under (b)(4).Where individual retrieval analysis is undertaken to confirm the presence of alumina in the poly bearing surface then these reviews will be attached to the complaint record on receipt of the approved document.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.

• Brand Name: DEPUY DUOFIX MBT TRAY SZ 5
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND-9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND-9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3905020
• MDR Text Key: 4672839
• Report Number: 1818910-2014-22381
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 900309000
• Device Lot Number: 2588562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR