MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER PERIARTICULAR LOCKING PLATE; TRAUMA PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: (b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the patient experienced infection two weeks following implantation.The patient required multiple debridement sessions.

Manufacturer Narrative

This complaint was identified during review of a journal article, so information about the case is limited.It is important to note there was an attempt to request additional information which was unsuccessful.The device history records could not be reviewed due to lack of product identification, no lot number provided.There was no particular product part or lot numbers provided, so a complaint review could not be performed.Due to this complaint being identified during review of a journal article there was no product returned; therefore, no physical evaluation could be conducted.Zimmer periarticular locking plates are used for treatment.A patient history review indicated that the patient underwent multiple debridement sessions to treat the infection, which were successful, and also has a history of breast cancer.Patient incurred an infection 2 weeks after the operation at the wound site; however, the implant remained intact.With the limited information, the exact cause of the infection cannot be determined.Additionally, single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified device caused any patient infection.

• Brand Name: UNKNOWN ZIMMER PERIARTICULAR LOCKING PLATE
• Type of Device: TRAUMA 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: 5278467
• MDR Text Key: 33053798
• Report Number: 1822565-2015-02612
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• 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: 01/04/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention