MAUDE Adverse Event Report: ZIMMER INC UNKNOWN NEXGEN TIVANIUM FEMORAL COMPONENT; KNEE PROSTHESIS

Device Problem Component Incompatible (1108)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It is reported that tivanium femur was implanted with a standard lps-flex articular surface, which is an incompatible combination.The surgeon feels that the tivanium femurs need to be marked more clearly.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: UNKNOWN NEXGEN TIVANIUM FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4663505
• MDR Text Key: 5683390
• Report Number: 1822565-2015-00495
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2015
• 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
• Treatment: UNKNOWN NEXGEN LPS-FLEX ARTICULAR SURFACE,; CATALOG # UNK, LOT # UNK
• Patient Outcome(s): Other