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

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that two patients with miller-galante unicompartmental knees had incomplete tibial cement-bone radiolucencies which initially appeared to be progressive but had not progressed after three years of follow-up.

Manufacturer Narrative

Information was received via published literature.No devices or photos were received; therefore the condition of the components is unknown.The device history records cannot be reviewed as 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.The journal article states that at the time of final radiographic evaluation, no component showed evidence of loosening.A definitive root cause cannot be determined with the information provided.Please reference literature at the following location: http://jbjs.Org/content/86/9/1931.

• Brand Name: UNKNOWN MILLER-GALANTE UNI TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4955887
• MDR Text Key: 6192119
• Report Number: 1822565-2015-01354
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• 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: 06/29/2015
• 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): Other