MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BI-METRIC/X POR COLLAR 13X145; PROSTHESIS, HIP

Model Number N/A

Device Problems Out-Of-Box Failure (2311); Device Packaging Compromised (2916); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/14/2015

Event Type  malfunction  

Manufacturer Narrative

The product and packaging was visually inspected and the hair had been taped to the ifu.The outer tray/lid were not returned and the inner lid had been removed from the inner tray.The inner nylon/nylon pouch was still intact.Based on the condition of the returned packaging, the hair must have been located on the inside of the inner tray/lid, but on the outside of the inner vacuum sealed nylon/nylon pouch.Inspection criteria clearly states that hair in not acceptable as a foreign material.This was a 6 unit lot and the remaining 5 products have been used without complaint, indicating that this is a single occurrence.The root cause was identified as operator error.Review of device history records found these units were released to distribution with no deviations or anomalies.Product returned was deemed nonconforming when it left biomet control.Nonconformance was addressed.Review of complaint history found no additional issues or trends.A summary of the investigation has been provided to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that when the package for the implant was opened, there was a hair laying on the sterile implant package.A backup implant was used to complete the procedure.There was no delay.No adverse events have been reported as a result of the malfunction.

• Brand Name: BI-METRIC/X POR COLLAR 13X145
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6939615
• MDR Text Key: 90180649
• Report Number: 0001825034-2017-08390
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: X181313
• Device Lot Number: 439240
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2014
• 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