MAUDE Adverse Event Report: ZIMMER GMBH MEDULLARY PLUG WITH DRAIN 2.5

Catalog Number 3228

Device Problem Component Missing (2306)

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

Event Date 01/20/2015

Event Type  Other  

Event Description

It was reported that the surgeon claimed because of a missing thread in the medullary plug with drain 2.5.He said that the medullary plug should have a thread in the center hole for the connection with a rod to allow the insertion of the plug in the femur.

Manufacturer Narrative

The mfr did not receive devices or other source documents for review.Where lot numbers were rec'd for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the info provided.Should add'l info become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Manufacturer Narrative

Additional information received on 06/09/2015.The manufacturer did not receive devices or other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Event Description

It has now been reported that on (b)(6) 2015 the surgeon wanted to implant a medullary plug with drain 2.5.He claimed because of a missing thread in the medullary plug.Therefore he decided to implant a device of another company.

Manufacturer Narrative

No trend identified.The device was not returned for investigation.It was reported that a surgeon was trying to insert the medullary plug and claimed that no thread was manufactured inside the plug which should help to fix it with other components.The technical drawing of the device has been reviewed and shows that the plug is designed without a thread.The surgical technique of the zimmer weber stem was also reviewed and shows that it describes how to correctly implant the medullary plug, it does not state at any point in the procedure about a thread inside the plug to help for implantation.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: MEDULLARY PLUG WITH DRAIN 2.5
• Type of Device: MEDULLARY PLUG
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 5742676
• MDR Report Key: 4847989
• MDR Text Key: 22152644
• Report Number: 9613350-2015-00660
• Device Sequence Number: 1
• Product Code: LZN
• 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,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 3228
• Device Lot Number: 2781384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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