MAUDE Adverse Event Report: ZIMMER INC ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT; HSX

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 09/15/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other devices used: catalog #00584200401, zimmer unicompartmental knee precoat tibial plate, lot #62172840.Catalog #00584202408, zimmer unicompartmental knee articular surface, lot #62200667.This report will be amended when our investigation is complete.

Event Description

It was reported that the patient was revised due to implant failure.

Manufacturer Narrative

No device or photographs were received; therefore the condition of the component is unknown.The device history records were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.These devices are used for treatment.A complaint history search based on all of the product and lot combinations revealed zero additional complaints.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Compatibility was assessed and the implants were found to be compatible.A definitive root cause cannot be determined with the information provided.However, the complaint may be revised upon return of product or further information.

Manufacturer Narrative

This report is being amended to reflect changes.

• Brand Name: ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT
• Type of Device: HSX
• 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: 5514639
• MDR Text Key: 40812958
• Report Number: 1822565-2016-00746
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2016

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
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00584201301
• Device Lot Number: 62165066
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/12/2016; 10/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2012
• 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): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 95