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

(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 0001825034-2017-02770.0001825034-2017-02771.0001825034-2017-02772.

Event Description

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

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable as there is no failure alleged against the device.The initial report was forwarded in error and should be voided.There was no debris in the sterile packaging.

• 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: 6547257
• MDR Text Key: 74514969
• Report Number: 0001825034-2017-02769
• 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: 04/24/2017

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: 3894433
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2016
• 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