MAUDE Adverse Event Report: ZIMMER, INC. TRABECULAR METAL TOTAL ANKLE TIBIAL BASE; ANKLE PROSTHESIS

Catalog Number 00830004300

Device Problem Insufficient Information (3190)

Patient Problems Impaired Healing (2378); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 08/05/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient had a re-operation due to experiencing a delayed healing following implantation of an ankle prosthesis.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.No device or photos were received; therefore the condition of the device is unknown.Design history records review indicates that all devices were manufactured to specifications for tibial base, talar component and tibial insert.This device used for treatment.An initial product history search was conducted and revealed no additional complaints against the related part and lot combination for tibial, talar or tibial insert.A definite root cause cannot be determined with the information provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 3 mdrs filed for the same patient (reference 1822565-2016-03371 / 03372).The patient's reoperation discharge summary was reviewed.The discharge summary states intraoperative cultures found staphylococcus epidermidis.This information does not change the root cause of the investigation previously reported.

Event Description

Patient underwent an irrigation and debridement procedure, hardware removal, and re-fixation of the ankle approximately two months following a total ankle arthroplasty due to delayed wound healing and wound breakdown.The patient was additionally administered a pic line four days following re-operation.

• Brand Name: TRABECULAR METAL TOTAL ANKLE TIBIAL BASE
• Type of Device: ANKLE 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 46580 ; 8006136131
• MDR Report Key: 5979341
• MDR Text Key: 55674674
• Report Number: 0001822565-2016-03369
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00830004300
• Device Lot Number: 63064163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 70