MAUDE Adverse Event Report: ZIMMER INC UNKNOWN NEXGEN TIBIAL COMPONENT; KNEE PROSTHESIS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

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 that asymptomatic radiographic subsidence of greater than 2mm was found in seven knees.At one year postoperatively, all subsidence settled with no progression thereafter.

Manufacturer Narrative

This report is being amended to reflect changes in sections.The part numbers and lot numbers are unknown; therefore the device history records could not be reviewed and a product history search for related complaints could not be conducted.No devices were received; therefore the condition of the components is unknown.This device is used for treatment.Bone quality of the 36 patients involved with this study was not stated in the article.The article did note that bone quality was not used as exclusion criteria for the study.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Per the nexgen tm tibia package insert, use of this device is contraindicated for patients with insufficient bone stock on the tibial surface.The journal article notes that there is potential concern about whether reduction osteotomy of a solid cortical layer forming the medial outer surface of the tibia reduces bone density around the tibial component and impairs fixation of the component, and it notes that use of an uncemented tibial component may further increase the risk of premature loosening or subsidence of the component.The mis multi-reference 4-in-1 femoral instrumentation system surgical technique states that the surgeon must determine the appropriate level of tibial resection based on patient age, bone quality and the type of prosthetic fixation planned.A definitive root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN NEXGEN TIBIAL COMPONENT
• Type of Device: KNEE 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: 5265443
• MDR Text Key: 32656900
• Report Number: 1822565-2015-02538
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/06/2015

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: 11/06/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• 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): Other