MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIGMA PS CEM FEM SZ2 R; KNEE FEMORAL COMPONENT

Catalog Number 196050200

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 10/02/2014

Event Type  malfunction  

Manufacturer Narrative

Examination of the package carton label did not confirm the reported event.The label exhibits a non-lugged femur as identified by the label information.The investigation did not find any evidence of product error and the need for corrective action is 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.

Event Description

The pictogram is showing the wrong product.Label shows a lugged version od knee prothesis which is not available in (b)(6).

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.

• Brand Name: SIGMA PS CEM FEM SZ2 R
• Type of Device: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4166263
• MDR Text Key: 16212507
• Report Number: 1818910-2014-29827
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 196050200
• Device Lot Number: 7788662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 10/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2013
• 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