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

Model Number N/A

Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

Cmp-(b)(4).Once the investigation has been completed, a follow up mdr will be submitted.(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02760.0001825034-2017-02761.0001825034-2017-02762.0001825034-2017-02763.0001825034-2017-02764.0001825034-2017-02768.0001825034-2017-02769.0001825034-2017-02771.0001825034-2017-02772.

Event Description

It was reported on incoming inspection that a foreign substance was inside of sterile packages.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the returned products identified that there is debris in sealed packaging.The complaint has been confirmed by visual evaluation.Material analysis could not determine the exact source of the debris.Dhr was reviewed and no discrepancies were found.The root cause of the reported event is attributed to manufacturing deficiency.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: 6547259
• MDR Text Key: 74514731
• Report Number: 0001825034-2017-02770
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 010000997
• Device Lot Number: 3895692
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• 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