MAUDE Adverse Event Report: ZIMMER INC ZIMMER BIGLIANI-FLATOW HUMERAL SHOULDER STEM; HSD

Catalog Number 00430001813

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.(b)(4).This report involves a multi-site study with the surgeries occurring in both (b)(6).It is unknown in which facility these events were documented.Please see below for the contact information for both sites.Unit of shoulder and elbow surgery(b)(6)this report will be amended when our investigation is complete.

Event Description

It is reported that radiolucent lines were found in three patients around the humeral component ( less than 0.5mm involving two zones in two patients with an uncemented component and greater than 1.5mm involving eight zones in one patient with a cemented component).However, the patients are asymptomatic.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

No device or photos were received since the device still remains implanted; therefore the condition of the component is unknown.Review of the device history records did not find any deviations or anomalies.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.Follow up communication states that radiolucent lines were found in zones 1, 5, 6 (ap view) and zones 9, 10, 12, 13 (axillary view).Product history search revealed no additional complaints against the related part and lot combination.A definite root cause cannot be determined with the information provided.

• Brand Name: ZIMMER BIGLIANI-FLATOW HUMERAL SHOULDER STEM
• Type of Device: HSD
• 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: 5475475
• MDR Text Key: 39520567
• Report Number: 1822565-2016-00567
• Device Sequence Number: 1
• Product Code: HSD
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 00430001813
• Device Lot Number: 61471182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2010
• 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): Other
• Patient Weight: 98