MAUDE Adverse Event Report: ZIMMER INC UNKNOWN MILLER-GALANTE UNI TIBIAL COMPONENT; KNEE PROSTHESIS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: http://www.Ncbi.Nlm.Nih.Gov/pubmed/26454570.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported one patient was revised due to collapse of tibial plateau.

Manufacturer Narrative

No devices or photos were received; therefore the condition of the components is unknown.As the part and lot numbers are unknown, a product history search could not be performed and compatibility could not be verified.This device is used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN MILLER-GALANTE UNI TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5213264
• MDR Text Key: 30845378
• Report Number: 1822565-2015-02335
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2015
• 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
• Patient Outcome(s): Required Intervention