MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 NEUTRAL E1 LINER 36MM G; HIP, PROSTHESIS

Model Number N/A

Device Problems Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

Udi # (b)(4).From visual inspection, it was observed that the blister had been subjected to prolonged heat which has caused the blister pack to deform.The cause of the deformation was traced back to the shrink wrapping operation of the manufacturing process, where the packaging was backed up in the shrink wrapper heat tunnel therefore the blister pack would have been subjected to prolonged heat causing it to deform.Even though the sterile packaging was deformed, the sterile barriers were not breached and the liner was unaffected.This device is used for treatment.(b)(4).If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that the sterile packaging was melted onto the device.Another device was used to complete the procedure.There was no delay in surgery or injury to the patient.

• Brand Name: G7 NEUTRAL E1 LINER 36MM G
• Type of Device: HIP, PROSTHESIS
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6345635
• MDR Text Key: 67863375
• Report Number: 0001825034-2017-00720
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000859
• Device Lot Number: 3559334
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• 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