MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER TIBIAL COMPONENT; ANKLE PROSTHESIS

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient is experiencing loosening of the ankle tibial component.Early on this was disabling but has lessened.She still gets a feeling of fatigue or aches with long walks.There is lucency anteriorly adjacent to the tibial component.

Manufacturer Narrative

No device or photos were received; therefore the condition of the component is unknown.Device history records cannot be reviewed since the part and lot number is unknown.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.Product history search cannot be completed since the part and lot number is unknown.Patient¿s adherence to rehabilitation protocol is unknown.A definite root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN ZIMMER TIBIAL COMPONENT
• 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 46581-0708 ; 8006136131
• MDR Report Key: 5708366
• MDR Text Key: 46855775
• Report Number: 0001822565-2016-01970
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• 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: 07/25/2016
• 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): Other