MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR STD NECK; PROSTHESIS HIP

Model Number N/A

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet.The complaint was confirmed.The package was found to have a hair in the outer tray.Inspection criterion i000051 clearly states that a hair is not acceptable as a foreign material.No further corrective/preventive action is required as the operator is no longer employed at zimmer biomet.Review of complaint history found no additional related issues for this item.Review of device history records found these units were released to distribution with no deviations or anomalies.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 by zimmer biomet (b)(4) that a hair was found in the sterile packaging of a cobalt chromium modular head during the inspection at arrival.

• Brand Name: 32MM MOD HEAD COCR STD NECK
• 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: 6939621
• MDR Text Key: 90179336
• Report Number: 0001825034-2017-08444
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK911684
• 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
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• 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: 163669
• Device Lot Number: 335410
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• 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