MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 ACETABULAR SYSTEM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.

Event Description

It was reported that when the sterilization package was opened, the product fell because the white protective material and the product adhered to the tyvek lid.Attempts for additional information are in progress, however no further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Complaint sample was evaluated and the reported event was not confirmed.Visual review of the returned product and packaging determined that the inner pouch of the device has been cut open and the foam insert is not adhered to the tyvek lid.The tyvek lid has been completely removed from the blister cavity and evidence of adhesive transfer exists around the full cavity flange.No foam was found adhered to the tyvek lid and no voids were found in the foam.Dhr was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was likely due to the inner pouch was lifted out of the blister when the lid was peeled back.If the inner pouch is pressed into the foam where the device mass is low the pouch can lift out of the blister with the lid and top foam.However, at this time a definitive root cause cannot be determined.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.

• Brand Name: G7 ACETABULAR SYSTEM
• Type of Device: PROSTHESIS, HIP
• 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: 6729446
• MDR Text Key: 80583217
• Report Number: 0001825034-2017-05018
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000848
• Device Lot Number: 6001293
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1