MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN FIBULAR PLATE; TRAUMA PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Information was received via journal article.Please reference literature at the following location: http://fai.Sagepub.Com/content/37/8/835.Full.Pdf+html.This report will be amended when our investigation is complete.

Event Description

It is reported that two patients underwent revision surgery due to symptomatic fibular hardware.

Manufacturer Narrative

The plate was not alleged to be a zimmer biomet product.

• Brand Name: UNKNOWN FIBULAR PLATE
• Type of Device: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5882493
• MDR Text Key: 52316922
• Report Number: 0001822565-2016-02850
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

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: 07/20/2016
• Initial Date FDA Received: 08/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention