MAUDE Adverse Event Report: ZIMMER TMT CONE ALIGNMENT ROD; IM POST

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

Device location unknown.

Event Description

It was reported that during cone rasping (with the stem extension and alignment rod in tibial canal) the alignment rod broke at the junction of stem extension.Part of the threads of the alignment rod are stuck inside the stem extension.No harm to the patient or operator was reported.

Manufacturer Narrative

The im post instrument was found to be compatible with the stem provisional that was used based upon the information that was reported; however, the broken im post instrument was not returned for this investigation since it was scrapped by the hospital.Therefore, a comparison between the topology of the fractured surface and that of an instrument with a confirmed static load failure could not be made.Failure as a result to static overloading of the im post instrument is likely; it cannot be confirmed in this specific case without examining the instrument itself.This investigation is considered closed at this time; however, should additional information become available, this investigation can be re-opened.

• Brand Name: CONE ALIGNMENT ROD
• Type of Device: IM POST
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 6543788
• MDR Text Key: 74598645
• Report Number: 3005751028-2017-00023
• Device Sequence Number: 1
• Product Code: LXT
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00545201320
• Device Lot Number: 80489729
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1